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药物临床试验登记与信息公示平台
首页 > 试验公示和查询 > 公示列表 >详细信息
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查询条件:   Xevinapant   Query criteria: Xevinapant
    目前是第 1 个试验/共 2 个试验    
Currently 1st trial/2 of 2
下一个试验  
登记号 Registration number CTR20222569 试验状态 Trial status 进行中 Ongoing
申请人联系人 Applicant Contact 夏言言 Xia Yanyan 首次公示信息日期 The date on which the information was first published 2022-10-12
申请人名称 Name of applicant 不适用/ 默克雪兰诺(北京)医药研发有限公司  N/A / Merck Seronno (Beijing) Pharmaceutical R&D Co., Ltd
一、题目和背景信息 1. Title and background information
登记号 Registration number CTR20222569
相关登记号 Relevant registration number
药物名称 The name of the drug Xevinapant口服溶液   曾用名:Debio 1143
Xevinapant Oral Solution formerly known as Debio 1143
药物类型 Type of medication 化学药物  Chemical drugs
临床申请受理号  Clinical application acceptance number 企业选择不公示  The company chooses not to make it public
适应症 Indications Xevinapant联合放疗(RT)适用于具有高复发风险且不适宜含顺铂化疗的已手术切除的局部晚期SCCHN的患者
Xevinapant plus radiotherapy (RT) is indicated for patients with surgically resected locally advanced SCCHN who are at high risk of recurrence and who are not candidates for cisplatin-based chemotherapy
试验专业题目 Experimental professional topics 一项在具有高复发风险且不适宜高剂量顺铂的已手术切除的头颈部鳞状细胞癌受试者中评估xevinapant和放疗与安慰剂和放疗相比的有效性和安全性并证明无病生存期改善的随机、双盲、安慰剂对照、双臂III期研究
A randomized, double-blind, placebo-controlled, two-arm phase III study to evaluate the efficacy and safety of xevinapant and radiotherapy compared with placebo and radiotherapy and demonstrate improved disease-free survival in subjects with surgically resected head and neck squamous cell carcinoma at high risk of recurrence who are not candidates for high-dose cisplatin
试验通俗题目 Experiment with popular topics 一项xevinapant和放疗联合治疗具有高风险且不适宜顺铂的已手术切除的LA SCCHN受试者的III期研究
A Phase III study of xevinapant in combination with radiotherapy in subjects with surgically resected LA SCCHN who are at high risk and not candidates for cisplatin
试验方案编号 Protocol number MS202359_0002 方案最新版本号  The latest version of the solution 第5.0版  Version 5.0
版本日期: Version Date: 2023-07-25 方案是否为联合用药 Whether the regimen is a combination of drugs
二、申请人信息 2. Applicant's information
申请人名称 Name of applicant
1
2
联系人姓名 Contact name 夏言言 Xia Yanyan 联系人座机 Contact desk phone 021-22265500 联系人手机号 The contact's mobile phone number 18758189762
联系人Email Contact Email ellie.xia@external.merckgroup.com 联系人邮政地址 Contact person postal address 上海市-上海市-浦东新区东育路227弄3号前滩世贸中心(二期)C栋15层
15th Floor, Building C, Qiantan World Trade Center (Phase II), No. 3, Lane 227, Dongyu Road, Shanghai - Pudong New Area
联系人邮编 Contact zip code 200126
三、临床试验信息 3. Clinical trial information
1、试验目的 1. The purpose of the test
本研究的目的是,证明xevinapant当添加到放疗方案时在不适宜接受以顺铂为基础的放化疗同步治疗的患有已手术切除的LA SCCHN的高风险受试者中的有效性优于安慰剂。
The purpose of this study is to demonstrate that xevinapant, when added to a radiotherapy regimen, is superior to placebo in high-risk subjects with surgically resected LA SCCHN who are not candidates for concomitant cisplatin-based chemoradiotherapy.
2、试验设计  2. Experimental design
试验分类 Classification of trials 安全性和有效性  Safety and efficacy 试验分期 Staging of the trial III期  Stage III 设计类型 Type of design 平行分组  Parallel grouping
随机化 randomization 随机化  randomization 盲法 Blinding 双盲  Double-blind 试验范围 Scope of the test 国际多中心试验  International multicenter trial
3、受试者信息 3. Subject information
年龄 age 18岁(最小年龄)至 无上限 (最大年龄)  18 years old (minimum age) to no upper limit (maximum age)
性别 gender 男+女  Male + Female
健康受试者 Healthy subjects
入选标准 Inclusion Criteria
1 签署知情同意书时年满18岁(或者根据国家法定成人年龄限制[如果>18岁的话])。
Be at least 18 years of age at the time of signing the informed consent form (or according to the national legal age limit for the adult [if > 18 years old]).
2 ECOG PS为0-2分,并且根据研究者的评估,能够耐受IMRT标准治疗。
ECOG PS score of 0-2 and, as assessed by the investigator, able to tolerate standard treatment with IMRT.
3 以下原发部位之一患有组织学确诊的鳞状细胞癌:口腔、口咽、下咽或喉。受试者在开始治疗(C1D1)前的过去4至8周内在这些部位接受了根治性手术(注:患有2种或2种以上原发性SCCHN肿瘤的受试者不适合参与本研究)。
Histologically confirmed squamous cell carcinoma at one of the following primary sites: oral cavity, oropharynx, hypopharynx, or larynx. Subjects have undergone radical surgery at these sites within the past 4 to 8 weeks prior to initiation of treatment (C1D1) (Note: subjects with 2 or more primary SCCHN tumors are not suitable for participation in this study).
4 通过使用免疫组织化学(IHC)检测p16表达确定患有HPV阴性口咽癌的受试者,患有以下病理分期(根据美国癌症联合委员会AJCC/TNM分期系统第8版的pTNM分期)的口腔癌、下咽癌或喉癌的受试者: pIII或 pIVA或pIVB 或 通过使用IHC检测p16表达确定患有HPV阳性口咽癌的受试者,他们必须为25包-年的吸烟者,且必须具有以下pTNM分期(根据AJCC/TNM分期系统第8版): pT3和pN2或 pT4和pN2 OPC受试者必须有已知的HPV状态,通过使用IHC检测p16表达确定(应提供病理报告)。
Subjects with HPV-negative oropharyngeal carcinoma as determined by immunohistochemistry (IHC) detection of p16 expression, subjects with the following pathologic stages (pTNM staging according to the American Joint Committee on Cancer AJCC/TNM Staging System, 8th Edition): pIII or pIVA or pIVB or Subjects with HPV-positive oropharyngeal carcinoma identified by IHC detection of p16 expression, they must be smokers of 25 pack-years, and must have the following pTNM staging (according to AJCC/TNM staging system version 8): pT3 and pN2 or pT4 and pN2 OPC subjects must have known HPV status, as determined by testing for p16 expression using IHC (pathology report should be provided).
5 如果当地法规允许,必须提供受试者的存档/放疗前FFPE肿瘤组织样本。
If local regulations allow, an archived/pre-radiotherapy FFPE tumor tissue sample from the subject must be provided.
6 通过CT和18F-FDG-PET检测无残留病灶,并具有符合1项或2项以下标准的高复发风险,并经当地组织病理学检查确认: 结节包膜外侵犯(ECE) 阳性切缘(R1或密切切缘≤1 mm)。
No residual disease detected by CT and 18F-FDG-PET with a high risk of recurrence that meets 1 or 2 of the following criteria, and confirmed by local histopathological examination: Nodular extracapsular invasion (ECE) Positive margins (R1 or close margins≤ 1 mm).
7 具有允许进行术后放疗的术后一般条件。  Has a postoperative general condition that allows for postoperative radiotherapy.
8 能够吞咽液体或放置足够功能的喂饲管、行胃造瘘术或空肠造口术。
Able to swallow liquids or place an adequately functional feeding tube, and have a gastrostomy or jejunostomy.
9 符合以下一项或多项标准不适宜接受高剂量顺铂:30 mL/min/1.73m的平方
High doses of cisplatin are not suitable if one or more of the following criteria are met: 30 mL/min/1.73 m squared
10 有足够的血液学和肝功能  Adequate hematologic and hepatic function
11 允许所有性别的受试者 避孕药的使用应符合当地对参与临床研究人员避孕方法的规定。
Subjects of all genders are allowed to use contraceptives in accordance with local regulations for contraceptive methods in participating clinical investigators.
12 能够提供签名的知情同意书,其中包括符合ICF和本方案中所列的要求和限制。
Able to provide signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and this protocol.
排除标准 Exclusion Criteria:
1 研究者认为对参与研究构成不适当风险或禁忌症或可能干扰研究目的、进行或评价的任何疾病,包括除SCCHN以外的任何未控制的疾病状态。
Any disease that, in the opinion of the investigator, poses an undue risk or contraindication to participation in the study or may interfere with the purpose, conduct, or evaluation of the study, including any uncontrolled disease state other than SCCHN.
2 鼻咽、副鼻窦、鼻腔、唾液腺、甲状腺或甲状旁腺、皮肤或未知原发部位的原发性肿瘤。
Primary tumors of the nasopharynx, paranasal sinuses, nasal cavity, salivary glands, thyroid or parathyroid glands, skin, or unknown primary site.
3 未完全切除手术(即R2切除)的受试者(AJCC/TNM,第8版)。
Subjects with incomplete resection surgery (i.e., R2 resection) (AJCC/TNM, 8th edition).
4 复发或转移性疾病(IVC期,根据AJCC/TNM,第8版)。
Recurrent or metastatic disease (stage IVC, according to AJCC/TNM, 8th edition).
5 已知的HIV感染史。  Known history of HIV infection.
6 慢性活动性HBV或HCV感染。  Chronic active HBV or HCV infection.
7 需要全身治疗的其他感染(病毒性[包括COVID-19]和/或细菌性和/或真菌性)
Other infections requiring systemic treatment (viral [including COVID-19] and/or bacterial and/or fungal)
8 已知的胃肠疾病,具有临床确定的吸收不良综合征,并且在过去12个月内进行了可能限制口服吸收的重大胃肠外科手术。
Known gastrointestinal disease with clinically determined malabsorption syndrome and major gastrointestinal surgery within the past 12 months that may limit oral absorption.
9 在术前最近4周内记录的体重下降>10%(除非采取了足够的营养支持措施),或血浆白蛋白<3.0 g/dL。随机化前2周内不允许输注白蛋白。
Weight loss of >10% (unless adequate nutritional support measures) or plasma albumin < 3.0 g/dL recorded in the last 4 weeks prior to surgery. Albumin infusion is not allowed for 2 weeks prior to randomization.
10 活动性胃肠出血,或任何其他需要2次以上红细胞输注的控制不佳的出血,或在随机化前4周内输注过4个单位及以上的浓缩红细胞。
Active gastrointestinal bleeding, or any other poorly controlled bleeding requiring more than 2 red blood cell transfusions, or transfusion of 4 or more units of packed red blood cells within 4 weeks prior to randomization.
11 需要持续接受抗TNF药物治疗的活动性炎症性疾病。
Active inflammatory disease requiring ongoing anti-TNF drug therapy.
12 心血管功能受损、有临床意义的心血管疾病或有临床意义的肺部疾病
Impaired cardiovascular function, clinically significant cardiovascular disease, or clinically significant pulmonary disease
13 随机化之前有其他恶性肿瘤病史,但以下除外:完全切除的头颈部以外的非黑色素瘤细胞皮肤癌或完全切除的I期乳腺癌或完全切除的原位非肌肉浸润性膀胱癌、宫颈癌和/或子宫癌或T1a食管鳞癌除外。 既往患有恶性肿瘤,接受过根治性治疗,在过去3年内没有复发,也没有抗癌治疗,并且不会干扰研究的安全性或有效性评估。
History of other malignancies prior to randomization, with the exception of the following: completely resected non-melanoma cell skin cancer other than the head and neck or completely resected stage I breast cancer or completely resected orthotopic non-muscle-invasive bladder cancer, cervical cancer, and/or uterine cancer or T1a esophageal squamous cell carcinoma. Prior malignancy, curative therapy, no recurrence within the past 3 years, and no anti-cancer therapy, and that would not interfere with the safety or efficacy assessment of the study.
14 非代偿性或症状性肝硬化(Child-Pugh评分:B或C)。
Uncompensated or symptomatic cirrhosis (Child-Pugh score: B or C).
15 先前对头颈部区域进行的可能影响原发肿瘤放疗计划的根治性、新辅助、同步或辅助(化)放疗,或任何其他既往SCCHN全身性治疗,包括试验性药物。
Prior curative, neoadjuvant, concurrent or adjuvant (chemical) radiotherapy to the head and neck region that may affect the radiotherapy plan for the primary tumor, or any other prior systemic therapy for SCCHN, including investigational agents.
16 使用以下治疗: 禁用药物。第6.8.3节进一步规定了这些药物和随机化前停用这些药物的时间窗。 在第一次研究治疗前4周内或在研究治疗期间,使用试验性药物或使用试验性器械治疗。 第一次研究治疗前28天内接种减毒活疫苗。 合并使用抗癌治疗。
The following treatments are used: Drugs are contraindicated. Section 6.8.3 further sets out the time window for these drugs and to discontinue them prior to randomization. Use of an investigational drug or treatment with an investigational device within 4 weeks prior to the first dose of study treatment or during study treatment. Administration of live attenuated vaccine within 28 days prior to the first dose of study treatment. Concomitant use of anticancer therapy.
17 活动性免疫缺陷患者或正在接受免疫抑制治疗的患者。
Patients with active immunodeficiency or those receiving immunosuppressive therapy.
18 在开始治疗前7天内,任何已知会延长QT间期且不能停药或通过安全替代药物替代的合并用药。
Any concomitant medication known to prolong the QT interval within 7 days prior to initiation of treatment and cannot be discontinued or replaced by a safe alternative medication.
19 在接受第一剂研究治疗前4周内接受过头颈部区域以外的重大外科干预治疗。允许进行活检以确定对SCCHN的诊断。
Significant surgical intervention outside the head and neck region within 4 weeks prior to receiving the first dose of study treatment. Biopsy is allowed to confirm the diagnosis of SCCHN.
20 既往器官移植,包括同种异体干细胞移植。  Prior organ transplantation, including allogeneic stem cell transplantation.
21 筛选前28天内或参与本研究期间参与任何其他临床研究。
Participation in any other clinical study within 28 days prior to screening or during participation in this study.
22 已知禁忌接受正电子发射断层扫描及18F-FDG-PET-CT扫描或对比剂增强的MRI和对比剂增强的CT扫描。
Positron emission tomography with 18F-FDG-PET-CT scan or contrast-enhanced MRI and contrast-enhanced CT scans are known to contraindicate undergoing positron emission tomography.
23 已知对xevinapant或xevinapant或安慰剂制剂中已知存在的任何辅料过敏。
Known hypersensitivity to xevinapant or any excipient known to be present in xevinapant or placebo formulations.
24 妊娠或授乳(哺乳)期女性。  Pregnant or lactating (lactating) females.
25 任何社会、个人、医疗和/或心理因素,包括目前的酒精和/或药物滥用,可能会影响研究者对受试者遵守方案和/或随访和/或知情同意书签署情况的判断。
Any social, personal, medical, and/or psychological factors, including current alcohol and/or drug abuse, that may affect the investigator's judgment regarding the subject's compliance with the protocol and/or follow-up and/or the signing of the informed consent form.
4、试验分组 4. Test grouping
试验药 Investigational drug
序号 serial number 名称 name 用法 usage
1 中文通用名:Xevinapant口服溶液  Chinese generic name: Xevinapant oral solution
英文通用名:Xevinapant Oral Solution
商品名称:NA   Product name: NA
剂型:口服溶液剂  Dosage form: oral solution
规格:200mg(20mg/ml)  Specification: 200mg(20mg/ml)
用法用量:200 mg/ 天  Dosage: 200 mg/day
用药时程:3个周期的xevinapant(口服溶液200 mg/天,第1天-第14天,每3周一个周期)+IMRT(66 Gy/33次分割,2 Gy/分割,5天/周),随后为3个周期的xevinapant单药治疗(口服溶液200 mg/天,第1天-第14天,每3周一个周期)
Duration of administration: 3 cycles of xevinapant (200 mg/day orally, day 1-14, every 3 weeks) + IMRT (66 Gy/33 fractions, 2 Gy/fraction, 5 days/week), followed by 3 cycles of xevinapant monotherapy (200 mg/day orally, days 1-14, every 3-week cycle)
2 中文通用名:Xevinapant口服溶液  Chinese generic name: Xevinapant oral solution
英文通用名:Xevinapant Oral Solution
商品名称:NA   Product name: NA
剂型:口服溶液剂  Dosage form: oral solution
规格:200mg(20mg/ml)  Specification: 200mg(20mg/ml)
用法用量:200 mg/ 天  Dosage: 200 mg/day
用药时程:3个周期的xevinapant(口服溶液200 mg/天,第1天-第14天,每3周一个周期)+IMRT(66 Gy/33次分割,2 Gy/分割,5天/周),随后为3个周期的xevinapant单药治疗(口服溶液200 mg/天,第1天-第14天,每3周一个周期)
Duration of administration: 3 cycles of xevinapant (200 mg/day orally, day 1-14, every 3 weeks) + IMRT (66 Gy/33 fractions, 2 Gy/fraction, 5 days/week), followed by 3 cycles of xevinapant monotherapy (200 mg/day orally, days 1-14, every 3-week cycle)
对照药 Comparator
序号 serial number 名称 name 用法 usage
1 中文通用名:安慰剂  Chinese generic name: placebo
英文通用名:Placebo  Common name in English: Placebo
商品名称:NA   Product name: NA
剂型:口服溶液剂  Dosage form: oral solution
规格:200mg(20mg/ml)  Specification: 200mg(20mg/ml)
用法用量:200 mg/天  Dosage: 200 mg/day
用药时程:3个周期的安慰剂(相匹配口服溶液,第1天-第14天,每3周一个周期)+IMRT(66 Gy/33次分割,2 Gy/分割,5天/周),随后为3个周期的安慰剂单药治疗(相匹配口服溶液,第1天-第14天,每3周一个周期)
Duration of administration: 3 cycles of placebo (matching oral solution, day 1-14, every 3 weeks cycle) + IMRT (66 Gy/33 fractions, 2 Gy/fraction, 5 days/week), followed by 3 cycles of placebo monotherapy (matching oral solution, day 1-14, every 3 weeks cycle)
2 中文通用名:安慰剂  Chinese generic name: placebo
英文通用名:Placebo  Common name in English: Placebo
商品名称:NA   Product name: NA
剂型:口服溶液剂  Dosage form: oral solution
规格:200mg(20mg/ml)  Specification: 200mg(20mg/ml)
用法用量:200 mg/天  Dosage: 200 mg/day
用药时程:3个周期的安慰剂(相匹配口服溶液,第1天-第14天,每3周一个周期)+IMRT(66 Gy/33次分割,2 Gy/分割,5天/周),随后为3个周期的安慰剂单药治疗(相匹配口服溶液,第1天-第14天,每3周一个周期)
Duration of administration: 3 cycles of placebo (matching oral solution, day 1-14, every 3 weeks cycle) + IMRT (66 Gy/33 fractions, 2 Gy/fraction, 5 days/week), followed by 3 cycles of placebo monotherapy (matching oral solution, day 1-14, every 3 weeks cycle)
3 中文通用名:安慰剂  Chinese generic name: placebo
英文通用名:Placebo  Common name in English: Placebo
商品名称:NA   Product name: NA
剂型:口服溶液剂  Dosage form: oral solution
规格:200mg(20mg/ml)  Specification: 200mg(20mg/ml)
用法用量:200 mg/天  Dosage: 200 mg/day
用药时程:3个周期的安慰剂(相匹配口服溶液,第1天-第14天,每3周一个周期)+IMRT(66 Gy/33次分割,2 Gy/分割,5天/周),随后为3个周期的安慰剂单药治疗(相匹配口服溶液,第1天-第14天,每3周一个周期)
Duration of administration: 3 cycles of placebo (matching oral solution, day 1-14, every 3 weeks cycle) + IMRT (66 Gy/33 fractions, 2 Gy/fraction, 5 days/week), followed by 3 cycles of placebo monotherapy (matching oral solution, day 1-14, every 3 weeks cycle)
5、终点指标 5. Endpoint indicators
主要终点指标及评价时间 The main endpoint indicators and evaluation time
序号 serial number 指标 index 评价时间 Evaluation time 终点指标选择 Endpoint metric selection
1 从随机化到以下任何事件首次发生的时间(在末次可评价评估或随机化后的2次计划DFS评估内发生): 因任何原因死亡 客观疾病复发
Time from randomization to the first occurrence of any of the following events (occurring within the last evaluable assessment or 2 planned DFS assessments after randomization): Death due to any cause Objective disease recurrence
直至20周 Up to 20 weeks 有效性指标  Effectiveness metrics
次要终点指标及评价时间 Secondary endpoint measures and evaluation time
序号 serial number 指标 index 评价时间 Evaluation time 终点指标选择 Endpoint metric selection
1 从随机化日期到死亡日期的时间。 Time from the date of randomization to the date of death. 直至20周 Up to 20 weeks 有效性指标  Effectiveness metrics
2 至后续癌症治疗的时间,从随机化到开始第一次后续癌症治疗的时间
Time to follow-up cancer treatment, from randomization to initiation of first follow-up cancer treatment
直至20周 Up to 20 weeks 有效性指标  Effectiveness metrics
3 发生AE和治疗相关AE Occurrence of AEs and treatment-related AEs 直至20周 Up to 20 weeks 安全性指标  Safety metrics
4 EORTC QLQ-HN35子量表评分(头颈部疼痛、吞咽困难和讲话困难)相对于基线的变化
Change from baseline in EORTC QLQ-HN35 subscale score (head and neck pain, dysphagia, and difficulty speaking).
直至20周 Up to 20 weeks 有效性指标+安全性指标  Effectiveness index + safety index
5 EORTC QLQ-C30子量表评分(疲乏、身体功能和总体健康状况)相对于基线的变化
Change from baseline in EORTC QLQ-C30 subscale score (fatigue, physical function, and general health status).
直至20周 Up to 20 weeks 有效性指标+安全性指标  Effectiveness index + safety index
6 EQ-5D-5L VAS相对于基线的变化 Change from baseline in EQ-5D-5L VAS 直至20周 Up to 20 weeks 有效性指标+安全性指标  Effectiveness index + safety index
6、数据安全监查委员会(DMC)  6. Data Security Audit Committee (DMC)
7、是否购买保险   7. Whether to buy insurance
四、研究者信息  4. Investigator information
1、主要研究者信息 1. Information of the principal investigator
1 姓名 name 杨坤禹 Yang Kunyu 学位 degree 医学博士 MD 职称 job title 正高级 It is advanced
电话 Phone 13995595360 Email yangky71@aliyun.com 邮政地址 Postal address 湖北省-武汉市-江汉路解放大道1277号 Hubei Province - Wuhan City - Jianghan Road Jiefang Avenue No. 1277
邮编 Zip 430022 单位名称 The name of the organization 华中科技大学同济医学院附属协和医院 Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
2、各参加机构信息 2. Information of each participating institution
序号 serial number 机构名称 Name of the institution 主要研究者 Principal Investigator 国家或地区 Country 省(州) Province (State) 城市 city
1 华中科技大学同济医学院附属协和医院 Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology 杨坤禹 Yang Kunyu 中国 China 湖北省 Hubei Province 武汉市 Wuhan
2 湖南省肿瘤医院 Hunan Provincial Cancer Hospital 韩亚骞 Han Yaqian 中国 China 湖南省 Hunan Province 长沙市 Changsha city
3 福建省肿瘤医院 Fujian Provincial Cancer Hospital 林少俊 Lin Shaojun 中国 China 福建省 Fujian Province 福州市 Fuzhou City
4 浙江大学医学院附属邵逸夫医院 Sir Run Run Shaw Hospital, Zhejiang University School of Medicine 孙晓南 Sun Xiaonan 中国 China 浙江省 Zhejiang Province 杭州市 Hangzhou City
5 浙江省肿瘤医院 Zhejiang Provincial Cancer Hospital 陈晓钟 Chen Xiaozhong 中国 China 浙江省 Zhejiang Province 杭州市 Hangzhou City
6 苏北人民医院 Subei People's Hospital 汪步海 Wang Buhai 中国 China 江苏省 Jiangsu Province 扬州市 Yangzhou City
7 四川大学华西医院 West China Hospital, Sichuan University 刘磊 Liu Lei 中国 China 四川省 Sichuan Province 成都市 Chengdu City
8 山东省肿瘤医院 Shandong Provincial Cancer Hospital 胡漫 Hu Man 中国 China 山东省 Shandong Province 济南市 Jinan city
9 重庆大学附属肿瘤医院 Affiliated Cancer Hospital of Chongqing University 谢悦 Xie Yue 中国 China 重庆市 Chongqing Municipality 重庆市 Chongqing Municipality
10 江西省肿瘤医院 Jiangxi Provincial Cancer Hospital 李金高 Li Jingao 中国 China 江西省 Jiangxi Province 南昌市 Nanchang city
11 四川省肿瘤医院 Sichuan Provincial Cancer Hospital 冯梅 Feng Mei 中国 China 四川省 Sichuan Province 成都市 Chengdu City
12 吉林大学第一医院 The First Hospital of Jilin University 姜新 Jiang Xin 中国 China 吉林省 Jilin Province 长春市 Changchun city
13 广西壮族自治区肿瘤医院 (广西医科大学附属肿瘤医院)
Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)
曲颂 Song Song 中国 China 广西壮族自治区 Guangxi Zhuang Autonomous Region 南宁市 Nanning
14 天津市肿瘤医院 Tianjin Cancer Hospital 王佩国 Wang Peiguo 中国 China 天津市 Tianjin City 天津市 Tianjin City
15 复旦大学附属肿瘤医院 Fudan University Cancer Hospital 胡超苏 Hu Chaosu 中国 China 上海市 Shanghai 上海市 Shanghai
16 Instituto de Oncologia Angel Roffo Giglio, Raul Eduardo Argentina Ciudad Autonoma Buenos Aires Ciudad Autonoma Buenos Aires
17 Centro Oncologico Riojano Integral (CORI) Kaen, Diego Lucas Argentina La Rioja La Rioja
18 Clinica Viedma S.A. Kowalyszyn, Ruben Argentina Rio Negro Viedma
19 CEMAIC - Centro Medico Privado Salinas, Jorge Emilio Argentina Cordoba Cordoba
20 Fundacion Scherbovsky Sola, Alejandro Argentina Mendoza Mendoza
21 Krankenhaus der barmherzigen Schwestern Linz Burian, Martin Austria NA Linz
22 LKH - Universitatsklinikum der PMU Salzburg Greil, Richard Austria NA Salzburg
23 LKH - Universitatsklinikum Graz Thurnher, Dietmar Austria NA Graz
24 Cliniques Universitaires Saint-Luc Machiels, Jean-Pascal Belgium NA Bruxelles
25 UZA Rasschaert, Marika Belgium NA Namur
26 Oncosite - Centro de Pesquisa Clinica e Oncologia Andre Franke, Fabio Brazil Rio Grande do Sul Ijui
27 Irmandade da Santa Casa de Misericordia de Porto Alegre Arima Tiscoski, Katsuki Brazil Rio Grande do Sul Porto Alegre
28 HGB - Hospital Giovanni Battista - Mae de Deus Center
HGB - Hospital Giovanni Battista - Mother of God Center
Arrieira Azambuja, Alan Brazil Rio Grande do Sul Porto Alegre
29 Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos Cancer Hospital - Pius XII Foundation
Baston Silva, Carlos Brazil Sao Paulo Barretos
30 INCA - Instituto Nacional de Cancer Dutra, Jamille Brazil Rio do Janeiro Rio do Janeiro
31 Hospital de Clínicas de Porto Alegre Jobim de Azevedo, Sergio Brazil Rio Grande do Sul Porto Alegre
32 Instituto de Cancer de Londrina Menacho de Oliveira, Rivadavio Antunes Brazil Parana Londrina
33 Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer
Erasto Gaertner Hospital - Paranaense League for the Fight against Cancer
Martinelli de Oliveira, Fabrício Augusto Brazil Martinelli de Oliveira, Fabrício Augusto Curitiba
34 Grupo Oncoclínicas Martins De Marchi, Pedro Rafael Brazil Rio do Janeiro Rio do Janeiro
35 ICESP - Instituto do Cancer do Estado de S?o Paulo Octavio Frias de Oliveira
ICESP - Cancer Institute of the State of São Paulo Octavio Frias de Oliveira
Perez Mak, Milena Brazil Sao Paulo Sao Paulo
36 CRIO - Centro Regional Integrado de Oncologia Pinto Figueiredo Lima, Iane Brazil Ceará Fortaleza
37 CEPON - Centro de Pesquisas Oncológicas de Santa Catarina Pontes Grando, Fabricio Brazil Santa Catarina Florianópolis
38 Liga Norte-Rio-Grandense Contra o Cancer Sales, Silvio Brazil Rio Grande do Norte Natal
39 CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
CEPHO - Center for Studies and Research in Hematology and Oncology
Vaz de Melo Sette, Claudia Brazil Sao Paulo Santo Andre
40 Hospital Beneficencia Portuguesa de Sao Paulo Vieira dos Santos, Lucas Brazil Vieira dos Santos, Lucas Sao Paulo
41 Fakultni nemocnice Bulovka Holeckova, Petra Czech Republic NA Praha
42 Fakultni nemocnice Olomouc Melichar, Bohuslav Czech Republic NA Olomouc
43 Hopital Prive Drome Ardeche Bosset, Matthieu France Ardeche Guilherand Granges
44 CHU Tours - Hopital Bretonneau Chapet, Sophie France Indre et Loire Tours cedex
45 CHU Bordeaux Daste, Amaury France Gironde Bordeaux cedex
46 Hopital Tenon Huguet, Florence France Paris Paris
47 Centre Azureen Cancerologie Lenglet, Alexis France Alpes Maritimes Mougins
48 Centre Oscar Lambret Liem, Xavier France Nord Lille cedex
49 ICO - Site René Gauducheau Rolland, Frederic France Loire Atlantique Saint Herblain
50 Hopital de la Timone Salas, Sebastien France Bouches-du-Rh?ne Bouches-du-Rh? ne Marseille Cedex 5
51 CHU Brest - Hopital Morvan Schick, Ulrike France Finistere Brest Cedex
52 Institut Gustave Roussy Tao, Yungan France Val de Marne Villejuif cedex
53 CHI Toulon La Seyne - Hopital Sainte Musse Tchiknavorian, Xavier France Var Toulon cedex
54 Centre Henri Becquerel Thureau, Sebastien France Seine Maritime Rouen
55 Centre Georges Francois Leclerc Vulquin, Noemie France Cote-d'Or Dijon Cedex
56 Universitaetsklinikum Schleswig-Holstein - Campus Kiel
University Medical Center Schleswig-Holstein - Campus Kiel
Domschikowski, Justus Germany Schleswig Holstein Kiel
57 Universitaetsklinikum Jena Guntinas-Lichius, Orlando Germany Thueringen Jena
58 Universitaetsmedizin Rostock Hildebrandt, Guido Germany Mecklenburg Vorpommern Rostock
59 Universitaetsklinikum Leipzig Kuhnt, Thomas Germany Bayern Regensburg
60 Universitaetsklinikum Giessen und Marburg GmbH Langer, Christine Germany Hessen Marburg
61 Vivantes Klinikum Neukoelln de Wit, Maike Germany Berlin Berlin
62 Caritasklinik St. Theresia Topaly, Julian Germany Saarland Saarbruecken
63 Tata Medical Centre Chatterjee, Sanjoy India West Bengal Kolkata
64 Regional Cancer Centre Kumar, Rejnish India Kerala Thiruvananthapuram
65 National Cancer Institute Nagpur Pathak, Anand India Maharashtra Nagpur
66 Chaim Sheba Medical Center Gluck, Iris Israel NA Ramat Gan
67 Soroka University Medical Center Meirovitz, Amichay Israel NA Beer sheva
68 Hadassah University Hospital - Ein Kerem Popovtzer, Aron Israel NA Yerushalayim
69 Rambam Health Care Center Salman, Saeed Israel NA Haifa
70 University of Pittsburgh Medical Center Health System Ferris, Robert United States Pennsylvania Pittsburgh
71 Montefiore Medical Center Radiology Kabarriti, Rafi United States New York Bronx
72 Greenville Hospital System University Medical Center (ITOR) O'Neal, Richard United States South Carolina Greenville
73 Barbara Ann Karmanos Cancer Institute Sukari, Ammar United States Michigan Detroit
74 University of Cincinnati Cancer Institute Medek, Sara United States Ohio Cincinnati
75 Dana-Farber Cancer Institute Haddad, Robert United States Massachusetts Boston
76 University of Alabama at Birmingham Bonner, James United States Alabama Birmingham
77 Perlmutter Cancer Center at NYU Langone Hospital ae Long Island Li, Zujun United States New York New York
78 CHUM Centre de Recherche Soulieres, Denis Canada Quebec Montreal
79 Centro de Atencion e Investigacion Clinica en Oncologia Molina Alavez, Alejandro Mexico Yucatan Merida
80 Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde Ramirez Godinez, Francisco Javier Mexico Jalisco Guadalajara
81 Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José Eleuterio González
Oyervides Juarez, Victor Manuel Mexico Nuevo Leon Monterrey
82 Hospital Santa Izabel - Santa Casa de Misericordia da Bahia Brito, Daniel Brazil Bahia Salvador
83 Yokohama City University Hospital Oridate, Nobuhiko Japan Kanagawa-Ken Yokohama-shi
84 NHO Hokkaido Cancer Center Ueda, Michihiro Japan Hokkaido Sapporo-shi
85 Osaka International Cancer Institute Fujii, Takashi Japan Osaka-Fu Osaka-shi
86 Cancer Institute Hospital of JFCR Tomomatsu, Junichi Japan Tokyo-To Koto-ku
87 Aichi Cancer Center Hospital Hanai, Nobuhiro Japan Aichi-Ken Nagoya-shi
88 Kindai University Hospital Tanaka, Kaoru Japan Osaka-Fu Osakasayama-shi
89 Hiroshima University Hospital Ueda, Tsutomu Japan Hiroshima-Ken Hiroshima-shi
90 National Cancer Center Hospital Murakami, Naoya Japan Tokyo-To Chuo-ku
91 Okayama University Hospital Ando, Mizuo Japan Okayama-Ken Okayama-shi
92 National Cancer Center Hospital East Tahara, Makoto Japan Chiba-Ken Kashiwa-shi
93 Nagoya University Hospital Nishio, Naoki Japan Aichi-Ken Nagoya-shi
94 Kobe University Hospital Kiyota, Naomi Japan Hyogo-Ken Kobe-shi
95 Tohoku University Hospital Katori, Yukio Japan Miyagi-Ken Sendai-shi
96 Saitama Cancer Center Shirakura, Satoshi Japan Saitama-Ken Kitaadachi-gun
97 Kagawa University Hospital Okita, Yoshihiro Japan Kagawa-Ken Kita-gun
98 Pusan National University Yangsan Hospital Oh, So Yeon Korea, Republic of Gyeongsangnam-do Yangsan-si
99 Seoul National University Bundang Hospital Kim, Ji-Won Korea, Republic of Gyeonggi-do Seongnam
100 Severance Hospital, Yonsei University Health System Kim, Hye Ryun Korea, Republic of NA Seoul
101 Chonnam National University Hwasun Hospital Shim, Hyun Jeong Korea, Republic of Jeollanam-do Hwasun-gun
102 Seoul National University Hospital Keam, Bhumsuk Korea, Republic of NA Seoul
103 Konkuk University Medical Center Park, Ji-Hyun Korea, Republic of NA Seoul
104 The Catholic University of Korea, St. Vincent's Hospital An, Ho Jung Korea, Republic of Gyeonggi-do Suwon-si
105 Korea University Anam Hospital Shin, Sang-Won Korea, Republic of NA Seoul
106 Kaohsiung Medical University Chung-Ho Memorial Hospital Wang, Hui-Ching 中国台湾 Taiwan, China NA Kaohsiung
107 National Taiwan University Hospital Lou, Pei-Jen 中国台湾 Taiwan, China NA Taipei
108 National Cheng Kung University Hospital Wu, Shang-Yin 中国台湾 Taiwan, China NA Tainan
109 Kaohsiung Chang Gung Memorial Hospital Chiu, Tai-Jan 中国台湾 Taiwan, China NA Kaohsiung
110 Chi Mei Hospital, Liouying Lin, Chien-Liang 中国台湾 Taiwan, China NA Tainan
111 Chang Gung Memorial Hospital,Linkou Chang, Tung-Chieh 中国台湾 Taiwan, China NA Taoyuan County
112 Taipei Veterans General Hospital Yang, Muh-Hwa 中国台湾 Taiwan, China NA Taipei City
113 China Medical University Hospital Lien, Ming-Yu 中国台湾 Taiwan, China NA Taichung
114 Changhua Christian Medical Foundation Changhua Christian Hospital Lin, Jin-Ching 中国台湾 Taiwan, China NA Changhua
115 Tata Memorial Hospital Noronha, Vanita India Maharashtra Mumbai
116 All India Institute of Medical Sciences Sharma, Atul India Delhi New Delhi
117 KABEG-Klinikum Klagenfurt Eckel, Hans Edmund Austria NA Klagenfurt am Worthersee
118 Vitaz Lybaert, Willem Belgium NA Sint Niklaas
119 Fakultni nemocnice Kralovske Vinohrady Lickova, Katerina Czech Republic NA Praha 10
120 Clinique Victor Hugo - Centre Jean Bernard Pointreau, Yoann France Sarthe Le Mans Cedex 02
121 Centre Hospitalier Prive Saint-Gregoire (Rennes) Riet, Francois Georges France Ille et Vilaine Saint Gregoire
122 Institut Regional du Cancer de Montpellier Boisselier, Pierre France Herault Montpellier
123 ICO - Site Paul Papin Goineau, Aurore France Maine et Loire Angers Cedex 2
124 Centre Hospitalier de la Croix Rousse Lapierre, Ariane France Rhone Criox-Rousse
125 Centre Antoine Lacassagne Saada-Bouzid, Esma France Alpes Maritimes Nice
126 CHU Poitiers - Hopital la Miletrie Evrard, Camille France Vienne Poitiers
127 Institut Claudius Regaud Modesto, Anouchka France Haute Garonne Toulouse cedex 09
128 Institut de Cancerologie de Strasbourg Europe - ICANS Borel, Christian France Bas Rhin Strasbourg
129 Centre Hospitalier de Bretagne Sud Sire, Christian France Morbihan Lorient cedex
130 High Technology Medical Center, University Clinic Gogishvili, Miranda Georgia NA Tbilisi
131 New Hospitals Giorgadze, Davit Georgia NA Tbilisi
132 Interbalkan Hospital of Thessaloniki Baka, Sofia Greece NA Thessaloniki
133 University General Hospital Psyrri, Amanda Greece NA Athens
134 General Hospital of Athens of Chest Diseases Syrigos, Konstantinos Greece NA Athens
135 A.O.U. Policlinico di Modena Bertolini, Federica Italy Modena Modena
136 Azienda Ospedaliera Universitaria Careggi Livi, Lorenzo Italy Firenze Firenze
137 IEO Istituto Europeo di Oncologia Nole, Franco Italy Milano Milano
138 Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Piedmont Foundation for Oncology IRCC Candiolo
Galizia, Danilo Italy Torino Candiolo
139 Ospedale San Raffaele Mirabile, Aurora Italy Milano Milano
140 IOV - Istituto Oncologico Veneto IRCCS Ghi, Mariagrazia Italy Padova Padova
141 Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agostino Gemelli University Hospital Foundation IRCCS
Valentini, Vincenzo Italy Roma Roma
142 Fondazione IRCCS Istituto Nazionale dei Tumori Licitra, Lisa Italy Milano Milano
143 Ospedale Oncologico Armando Businco Ghiani, Massimo Italy Cagliari Cagliari
144 IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
IRCCS Romagna Scientific Institute for the Study and Treatment of Tumors
De Rosa, Francesco Italy Forli - Cesena Meldola
145 Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza
Azienda Ospedaliera Universitaria Policlinico Umberto I - University of Rome La Sapienza
Botticelli, Andrea Italy Roma Roma
146 Azienda Ospedaliera Universitaria- Universita degli Studi della Campania “Luigi Vanvitelli”
University Hospital - University of Campania "Luigi Vanvitelli"
Fasano, Morena Italy Napoli Napoli
147 Istituto Nazionale Tumori Fondazione G. Pascale Perri, Francesco Italy Napoli Napoli
148 Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Buglione, Michela Italy Brescia Brescia
149 UMC Utrecht De Ridder, Mischa Netherlands NA Utrecht
150 Universitair Medisch Centrum Groningen Oosting, Sjoukje Netherlands NA Groningen
151 Amsterdam UMC, Locatie VUMC Buter, Jan Netherlands NA Amsterdam
152 Centrum Onkologii-Instytut im.M.Sklodowskiej Curie
Oncology Centre-Institute of M. Skłodowska-Curie
Rutkowski, Tomasz Poland NA Gliwice
153 Hospital de Braga Ferreira Pereira, Filipa Margarida Portugal NA Braga
154 Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE Vieira, Claudia Portugal NA Porto
155 Centro Hospitalar de Sao Joao, E.P.E Coelho, Andreia Portugal NA Porto
156 Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E. Monteiro, Ana Portugal NA Vila Nova de Gaia
157 S.C Medisprof S.R.L Udrea, Anghel Adrian Romania NA Cluj-Napoca
158 S.C Radiotherapy Center Cluj S.R.L Ungureanu, Andrei Romania NA Comuna Floresti
159 S.C Oncocenter Oncologie Clinica S.R.L Scheusan, Roxana-Ioana Romania NA Timisoara
160 S.C Centrul de Oncologie Sf. Nectarie S.R.L Schenker, Michael Romania NA Craiova
161 Centrul medical Focus Iordan, Ingrid Romania NA Bucuresti
162 Hospital Universitario Virgen del Rocio Flor Oncala, Maria Jose Spain Sevilla Sevilla
163 Clinica Universidad de Navarra (MAD) Serrano, Javier Spain Madrid Madrid
164 Hospital Regional Universitario de Malaga Rueda Dominguez, Antonio Spain Malaga Malaga
165 Hospital Universitario Fundacion Jimenez Diaz Rubio Perez, Jaime Spain Madrid Madrid
166 Hospital Universitario Lucus Augusti Hospital Universitario Lucus Augusti Spain Lugo Lugo
167 Complejo Hospitalario Universitario Insular Materno-Infantil Gomez de Liano Lista, Alfonso Spain Las Palmas Las Palmas de Gran Canaria
168 Hospital del Mar Corbera, Alex Spain Barcelona Barcelona
169 ICO l'Hospitalet - Hospital Duran i Reynals Oliva Bernal, Marc Spain Barcelona L'Hospitalet de Llobregat
170 Hospital Universitari Vall d'Hebron Giralt Lopez de Sagredo, Jordi Spain Barcelona Barcelona
171 ICO Badalona - Hospital Universitari Germans Trias i Pujol Ferrando, Angelica Spain Barcelona Barcelona
172 Complejo Hospitalario Universitario A Coruna Molina, Aurea Spain La Coruna A Coruna
173 Hospital Universitario La Paz Castelo Fernandez, Beatriz Spain Madrid Madrid
174 Hospital Clinic de Barcelona Baste Rotllan, Neus Spain Barcelona Barcelona
175 Universitaetsspital Basel Bunea, Andrei Switzerland NA Basel
176 CHUV, Lausanne University Hospital Cristina, Valérie Switzerland NA Lausanne
177 Universitaetsspital Zuerich Balermpas, Panagiotis Switzerland NA Zuerich
178 Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC)
Institute of Oncology of Southern Switzerland (IOSI) - Ente Ospedaliero Cantonale (EOC)
Espeli, Vittoria Switzerland NA Bellinzona
179 Inonu Uni. Med. Fac. Harputluoglu, Hakan Turkey NA Malatya
180 Gazi University Medical Faculty Yazici, Ozan Turkey NA Ankara
181 Trakya University Medical Faculty Hacioglu, Bekir Turkey NA Edirne
182 Adana City Hospital Cil, Timucin Turkey NA Adana
183 Izmir Medicalpark Hospital Arslan, Cagatay Turkey NA Izmir
184 Medipol University Medical Faculty Bilici, Ahmet Turkey NA Istanbul
185 Mount Vernon Hospital Chiu, Kevin United Kingdom Middlesex Middlesex
186 Royal Surrey County Hospital Mehta, Ajay United Kingdom Surrey Guildford
187 Clatterbridge Cancer Centre Clatterbridge Cancer Centre United Kingdom Merseyside Wirral
188 St James's University Hospital Sen, Mehmet United Kingdom West Yorkshire Leeds
189 Western General Hospital Western General Hospital United Kingdom Lothian Region Edinburgh
190 The Christie Hospital Hughes, Christopher United Kingdom Greater Manchester Greater Manchester
191 中南大学湘雅医院 Xiangya Hospital, Central South University 申良方 Shen Liangfang 中国 China 湖南省 Hunan Province 长沙市 Changsha city
192 北京肿瘤医院 Beijing Cancer Hospital 孙艳 Sun Yan 中国 China 北京市 Beijing 北京市 Beijing
193 上海市第一人民医院 Shanghai First People's Hospital 董频 Dong Pin 中国 China 上海市 Shanghai 上海市 Shanghai
194 河南省肿瘤医院 Henan Provincial Cancer Hospital 吴慧 Wu Hui 中国 China 河南省 Henan Province 郑州市 Zhengzhou City
195 安徽省肿瘤医院 Anhui Provincial Cancer Hospital 高劲 Gao Jin 中国 China 安徽省 Anhui Province 合肥市 Hefei City
196 中山大学肿瘤防治中心 (中山大学附属肿瘤医院) Sun Yat-sen University Cancer Center (Sun Yat-sen University Cancer Hospital) 吴少雄 Wu Shaoxiong 中国 China 广东省 Guangdong Province 广州市 Guangzhou City
197 南京鼓楼医院 Nanjing Drum Tower Hospital 闫婧 Yan Jing 中国 China 江苏省 Jiangsu Province 南京市 Nanjing
198 中国医科大学附属盛京医院 Shengjing Hospital Affiliated to China Medical University 刘彩刚 Liu Caigang 中国 China 辽宁省 Liaoning Province 沈阳市 Shenyang city
199 蚌埠医学院第一附属医院 The First Affiliated Hospital of Bengbu Medical College 张亚军 Zhang Yajun 中国 China 安徽省 Anhui Province 蚌埠市 Bengbu City
200 西安交大附属二院 The Second Affiliated Hospital of Xi'an Jiaotong University 马红兵 Ma Hongbing 中国 China 陕西省 Shaanxi Province 西安市 Xi'an City
201 Institut Jules Bordet Awada, Ahmad Belgium NA Anderlecht
202 High Technology Hospital Medcenter LLC Makharadze, Tamta Georgia NA Batumi
203 Evex Hospitals Oncology Center Natelauri, Eter Georgia NA Kutaisi
204 Cancer Research Center Ltd. Matitashvili, Amiran Georgia NA Tbilisi
205 Musgrove Park Hospital Jankowska, Petra United Kingdom Somerset Taunton
206 Royal Marsden Hospital- London Harrington, Kevin United Kingdom Greater London London
五、伦理委员会信息 V. Information on the Ethics Committee
序号 serial number 名称 name 审查结论 Conclusions of the review 批准日期/备案日期 Approval Date/Filing Date
1 华中科技大学同济医学院附属协和医院医学伦理委员会
Medical Ethics Committee of Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
同意  agree 2022-08-02
2 华中科技大学同济医学院附属协和医院医学伦理委员会
Medical Ethics Committee of Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
同意  agree 2023-02-27
3 华中科技大学同济医学院附属协和医院医学伦理委员会
Medical Ethics Committee of Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
同意  agree 2023-12-06
六、试验状态信息 6. Test status information
1、试验状态 1. Test status
进行中 (招募中)   Ongoing (Recruiting)
2、试验人数  2. The number of experiments
目标入组人数 Target enrollment 国内: 83 ; 国际: 700 ;  Domestic: 83 ; International: 700 ;
已入组人数 Number of people enrolled 国内: 19 ; 国际: 89 ;  Domestic: 19 ; International: 89 ;
实际入组总人数 The total number of people actually enrolled 国内: 登记人暂未填写该信息; 国际: 登记人暂未填写该信息;
Domestic: The registrant has not filled in this information yet; International: The registrant has not filled in this information yet;
3、受试者招募及试验完成日期 3. Subject recruitment and the date of completion of the trial
第一例受试者签署知情同意书日期 The date on which the first subject signed the informed consent form 国内:2022-10-06;     国际:2023-01-16;
Domestic:2022-10-06;     International:2023-01-16;
第一例受试者入组日期 Date of enrollment of the first subject 国内:2022-10-21;     国际:2023-02-12;
Domestic:2022-10-21;     International: 2023-02-12;
试验完成日期  The date of completion of the experiment 国内:登记人暂未填写该信息;     国际:登记人暂未填写该信息;
Domestic: The registrant has not filled in this information yet;     International: The registrant has not yet filled in this information;
七、临床试验结果摘要 7. Summary of clinical trial results
序号 serial number 版本号 Version number 版本日期 Version date
暂未填写此信息 This information is not filled in yet
    目前是第 1 个试验/共 2 个试验    
Currently 1st trial/2 of 2
下一个试验