ChiCTR2100049016 版本V1.2 版本创建时间2022/03/28 11:48:27 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2100049016 

最近更新日期：

Date of Last Refreshed on：

2022-03-28 11:46:27 

注册时间：

Date of Registration：

2021-07-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评估BR101注射液在晚期实体瘤患者中单药治疗的安全性、耐受性、药代动力学、免疫原性、抗肿瘤活性的开放、剂量递增和剂量扩展I期临床研究

Public title：

A phase I open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BR101 injection, as a single agent in subjects with advanced solid tumors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评估BR101注射液在晚期实体瘤患者中单药治疗的安全性、耐受性、药代动力学、免疫原性、抗肿瘤活性的开放、剂量递增和剂量扩展I期临床研究

Scientific title：

A phase I open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BR101 injection, as a single agent in subjects with advanced solid tumors

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

林樑 

研究负责人：

黄建 

Applicant：

Lin Liang 

Study leader：

Huang Jian 

申请注册联系人电话：

Applicant telephone：

+86 13817156157

研究负责人电话：

Study leader's telephone：

+86 571 87783759

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

liang.lin@bioraypharm.com

研究负责人电子邮件：

Study leader's E-mail：

hjys@zju.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

浙江省杭州市富阳区胥口镇海正路8号

研究负责人通讯地址：

浙江杭州市解放路88号

Applicant address：

8 Haizheng Road, Xukou Town, Fuyang District, Hangzhou, Zhejiang

Study leader's address：

88 Jiefang Road, Hangzhou, Zhejiang

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

浙江博锐生物制药有限公司

Applicant's institution：

Bioray Pharmaceutical Co.,Ltd.

研究负责人所在单位：

浙江大学医学院附属第二医院

Affiliation of the Leader：

The Second Affiliated Hospital of Zhejiang University Medical College

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

（2021）伦审药第（327）号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

浙江大学医学院附属第二医院人体研究伦理委员会

Name of the ethic committee：

Ethics Committee of the Second Affiliated Hospital of Medical College of Zhejiang University

伦理委员会批准日期：

Date of approved by ethic committee：

2021-05-13 00:00:00

伦理委员会联系人：

赵小英

Contact Name of the ethic committee：

Zhao Xiaoying

伦理委员会联系地址：

浙江省杭州市解放路88号

Contact Address of the ethic committee：

88 Jiefang Road, Hangzhou, Zhejiang

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 571 87783759

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

浙江大学医学院附属第二医院

Primary sponsor：

The Second Affiliated Hospital of Zhejiang University Medical College

研究实施负责（组长）单位地址：

浙江杭州市解放路88号

Primary sponsor's address：

88 Jiefang Road, Hangzhou, Zhejiang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

台州

Country：

China

Province：

Zhejiang

City：

Taizhou

单位(医院)：

浙江博锐生物制药有限公司

具体地址：

椒江区疏港大道1号

Institution
hospital：

Bioray Pharmaceutical Co.,Ltd.

Address：

1 Shugang Avenue, Jiaojiang District

经费或物资来源：

自筹

Source(s) of funding：

self-funded

Target disease：

Advanced solid tumor

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

单臂 

Study design：

Single arm 

研究目的：

1.Ⅰa期部分：评价BR101注射液单药（单次给药和多次给药）在晚期实体瘤受试者中的安全性和耐受性，确定最大耐受剂量（MTD）； 2.Ⅰb期部分：初步探索BR101单药治疗在晚期三阴性乳腺癌及晚期胰腺癌患者中的有效性，确定II期临床试验推荐剂量（RP2D）。  

Objectives of Study：

1. Phase Ia part: To evaluate the safety and tolerability of BR101 injection as a single drug (single and multiple doses) in subjects with advanced solid tumors, and determine the maximum tolerated dose (MTD); 2. Phase Ib: Preliminarily explore the efficacy of BR101 monotherapy in patients with advanced triple-negative breast cancer and advanced pancreatic cancer, and determine the recommended dose for phase II clinical trials (RP2D).

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.自愿签署知情同意书，理解本试验的性质、目的和试验程序并且能够依照方案完成试验者；
2.年龄≥18周岁（以签署知情同意书当天为准），男女均可；
3.经病理组织学和/或细胞学（仅限于细胞蜡块）确诊的无法进行根治性手术切除或已发生转移的晚期实体瘤患者，标准治疗失败或不耐受（疾病进展、或无法耐受化疗、靶向治疗等），或缺乏有效治疗方法的患者（注：Ⅰb期剂量扩展研究部分将根据Ⅰa期试验结果限定更为具体的受试者人群，初步拟定为晚期三阴性乳腺癌患者及晚期胰腺癌患者）；
4.根据RECIST V1.1实体肿瘤疗效评价标准，受试者至少有1个可测量病灶；
5.东部肿瘤协作组（ECOG）体力状态评分≤1；
6.受试者如过去曾接受过抗肿瘤治疗，应在以往治疗的毒性反应恢复至≤1级（根据CTCAE v 5.0）后（残留的脱发效应除外）；免疫相关的不良反应完全恢复；
7.具有充分的器官和骨髓功能（随机入组前14天内未使用任何细胞、生长因子、输血治疗或其他医学干预），定义如下：
（1)血常规：绝对中性粒细胞计数（ANC）≥1.5×10^9/L；血小板计数（PLT）≥100×10^9/L，血红蛋白含量（HGB）≥9.0 g/dL（肝癌患者可接受白细胞计数（WBC）≥ 3.05 × 10^9/L，血小板计数（PLT）≥ 70 × 10^9/L）；
（2)肝功能：血清总胆红素（TBIL）≤1.5×正常上限（ULN）（受试者有Gilbert综合征除外），丙氨酸氨基转移酶（ALT）和天门冬氨酸氨基转移酶（AST）≤2.5×ULN（在HCC或者具有肝转移的患者，ALT或AST≤5×ULN）；
（3)肾功能：血清肌酐（Cr）≤1.5×ULN或肌酐清除率（CCr）≥50mL/min，尿蛋白<2+，对基线时尿蛋白≥2+的患者，应进行24小时尿液采集且24小时内尿液中的蛋白含量<1g；
8.预计生存期超过12周；
9.有生育可能女性受试者进入本研究时血液人绒毛膜促性腺激素（HCG）必须为阴性；
10.有生殖能力的男性或有怀孕可能性的女性（指没有进行过节育手术的男性或女性，以及没有绝经的女性），必须在试验过程中使用高度有效的避孕方法（如口服避孕药、宫内避孕器、节制性欲或屏障避孕法结合杀精剂），且在最后一次给药后继续避孕6个月。

Inclusion criteria

1. Who voluntarily sign the informed consent form to understand the nature, purpose and test procedures and can complete the test in accordance with the protocol;
2. Aged >= 18 (whichever is on the day of signing the informed consent), both male and female;
3. Patients with advanced or metastatic solid tumors diagnosed by pathological histology and / or cytology (cell wax only) who are unable for radical surgical resection, or who have failed to standard treatment or who have been intolerant to standard treatment (disease progression, or intolerant to chemotherapy, targeted therapy, etc.), or who lack effective treatment (Note: the Phase Ib dose extension study will limit a more specific population according to phase Ia test results, initially proposed as patients with advanced three-negative breast cancer and advanced pancreatic cancer);
4. According to the Response Evaluation Criteria in Solid Tumors
of RECIST V1.1, the subject must have at least one measurable lesion;
5. Eastern ECOG physical status score <= 1;
6. If the subject has received anti-tumor treatment in the past, it should recover to <= Grade 1 (according to CTCAE v 5.0) (except for the residual hair loss effect); the immune-related adverse effects are completely restored;
7. Sufficient organ and bone marrow function (no cells, growth factors, blood transfusion therapy, or other medical interventions were used within 14 days before randomization), defined as follows:
1) Blood routine: absolute neutrophil count (ANC)>=1.5x10^9/L; platelet count (PLT)>=100x10^9/L, hemoglobin content (HGB)>=9.0 g/dL(liver cancer patients with acceptable leukocyte count (WBC)>= 3.05 x 10^9/L, platelet count (PLT)>= 70 x 10^9/L);
2) Liver function: Serum total bilirubin (TBIL) <= 1.5 x normal upper limit (ULN) (except subjects with Gilbert syndrome), alanine aminotransferase (ALT) and assparate aminotransferase (AST) <= 2.5 x ULN (in HCC or patients with liver metastasis, ALT or AST <= 5 x ULN);
3) Renal function: serum creatinine (Cr)<=1.5xULN or creatinine clearance rate (CCr)>=50mL/min, urinary protein <2+, at baseline Patients with urinary protein >=2+ should be collected in 24 hours of urine and <1g; in urine within 24 hours
8. The expected survival period exceeds 12 weeks;
9. Potential female subjects with blood must be negative (HCG) when entering this study;
10. Men with reproductive capacity or women likely to become pregnant (men or women without birth control surgery, and women without menopause) must use highly effective contraception (such as oral contraceptives, intrauterine contraceptives, abstinence or barrier control) during the trial and continue contraception for six months after the last administration.

排除标准：

1.存在任何活动性自身免疫病或有自身免疫病病史（受试者患有白癜风或在童年期哮喘已完全缓解，成人后无需任何干预的可纳入；受试者需要支气管扩张剂进行医学干预的哮喘则不能纳入）；
2.已知原发性免疫缺陷病史者；
3.曾患间质性肺病、化学性肺炎、过敏性肺炎、结缔组织病肺炎、肺纤维化、急性肺部疾病等（由放疗诱发的局部间质性肺炎除外）；
4.有活动性结核病或结核病史；
5.随机入组前14天内出现任何需要通过静脉输注进行全身治疗的活动性感染；
6.既往或目前存在2种或2种以上的原发肿瘤不能入组（不包括已治愈的宫颈原位癌、基底细胞癌或鳞状细胞皮肤癌，以及经治疗稳定超过5年的其他肿瘤）；
7.有症状或未经治疗的已知脑转移或其他中枢神经系统转移不可以入组。但已完全切除和/或放疗后证明稳定或改善的中枢神经系统转移可以入组，只要影像学（CT/MRI）显示在随机前稳定至少4周，且无脑水肿证据及无需糖皮质激素或抗惊厥药物；
8.药物治疗无法获得良好控制的高血压患者（收缩压＞150mmHg或舒张压＞100mmHg）；
9.具有下列任一心脏疾病者：按照美国纽约心脏病协会（NYHA）分级标准，目前患有任一级别的充血性心力衰竭病史，或严重的需要治疗的心律失常（房颤或阵发性室上性心动过速除外）或不稳定型心绞痛；心电图检查：QTc(F)≥480 ms或研究者判断不适合入组的心电图检查异常；
10.有心肌梗塞病史的患者或血肌钙蛋白T（TnT）检测大于0.15μg/L；
11.有精神病史者；
12.已知对单抗有严重过敏反应者（CTCAE v 5.0 分级＞3级），及有不受控制的过敏性哮喘病史的患者；
13.曾接受免疫治疗出现免疫相关性不良事件（immune-related AE）等级≥ 3级者（根据CTCAE v 5.0）；
14.随机入组前28天接受过全身性抗肿瘤治疗或参加其他临床研究且使用了其他试验相关药物者，包括化疗、靶向治疗、免疫治疗、生物治疗（肿瘤疫苗、细胞因子、或控制癌症的生长因子）等；
15.随机入组前28天内进行过重大手术或预期在研究期间实施重大手术，或随机入组前28天内进行过放射治疗，或随即入组前56天内使用过治疗性的放射药剂；
16.曾接受过异体器官移植史或异体造血干细胞移植史；
17.随机入组前7天内接受过抗肿瘤治疗的中药饮片或中成药；
18.具有出血倾向或正在接受溶栓或抗凝治疗者（用于维持静脉导管除外）；
19.签署知情同意书前3个月内曾接种过疫苗，或者有意向在研究期间接种疫苗者；
20.签署知情同意书前3个月内有献血史，或在试验期间计划献血者；
21.随机入组前14天内因某种状况需接受超过7天的皮质类固醇（甲泼尼龙>10 mg/天或等价剂量的其它同类药物）或其他免疫抑制剂治疗的受试者，吸入性皮质类固醇除外；
22.人类免疫缺陷病毒（HIV）抗体、丙型肝炎病毒（HCV）抗体、梅毒螺旋体（TP）抗体检测阳性者；乙型肝炎表面抗原阳性或乙型肝炎核心抗体阳性者，需进一步进行乙肝病毒DNA检测，若大于等于各医院参考值上限需排除；
23.目前患有影响静脉注射、静脉采血疾病者；
24.自签署知情同意书至末次试验用药品给药后6个月内计划捐献精子者；
25.存在已知或怀疑不能够遵守研究方案的情况（例如，酗酒、药物依赖或心理障碍），或按照研究者的意见对于参与本研究可能会增加风险的受试者；或存在研究者认为参加本研究并非其最佳选择（例如损害健康）或者影响、限制或混淆研究方案评估的病症；
26.研究者认为不适合入组或可能因为其他原因不能完成本试验者。

Exclusion criteria：

1. Subject who has any active autoimmune disease or a history of autoimmune (subjects with vitiligo or complete remission of asthma in childhood without any intervention in adults; asthma requiring bronchodilator for medical intervention is not included);
2. A known history of primary immunodeficiency;
3. Suffering from interstitial lung disease, chemical pneumonia, allergic pneumonia, connective tissue disease pneumonia, pulmonary fibrosis, acute pulmonary disease, etc. (except local stitial interstitial pneumonia induced by radiotherapy);
4. A history of active tuberculosis or tuberculosis;
5. Any active infection that requires systemic treatment through intravenous infusion within 14 days before randomization;
6. Two or more primary tumors remain present or present (excluding cured cervical in situ carcinoma, basal cell carcinoma or squamous cell skin cancer, and other tumors that have been treated for more than 5 years);
7. Known brain metastasis or other central nervous system metastasis with symptomatic or untreated treatment is not available in the group. However, CNS transfer that has been fully removed and stable or improved after / or radiotherapy can be enrolled, as long as imaging (CT/MRI) shows stabilization for at least 4 weeks before randomization and has no evidence of cerebral edema and no need for glucocorticoids or anticonvulsants;
8. Patients with hypertension who cannot in good control (systolic> 150mmHg or diastolic> 100mmHg);
9. Patients with any of the following heart diseases: current congestive heart failure or a severe arrhythmia requiiring treatment (except atrial fibrillation or paroxysmal supraventricular tachycardia) or unstable angina; ECG abnormalities: QTc (F) >= 480 ms or other ECG abnormalities that are not suitable for enrolling in the study judged by the investigator;
10. Patients with a history of myocardial infarction or T (TnT) were tested greater than 0.15 μg/L;
11. Have a history of mental illness;
12. Patients who are known to have severe allergic reactions to monomab (CTCAE v 5.0 grade> 3) and patients with an uncontrolled history of allergic asthma;
13. Those who had immunorelated adverse events (immune-related AE) grade >= 3 (according to CTCAE v 5.0);
14. People who have received systemic anti-tumor therapy or participated in other clinical studies and used other trial-related drugs 28 days before randomization, including chemotherapy, targeted therapy, immune therapy, biological therapy (tumor vaccines, cytokines, or growth factors that control cancer);
15. Major surgery was performed within 28 days before randomization or expected during the study, radiotherapy within 28 days before randomization, or therapeutic radioactive agents within 56 days prior to immediate enrollment;
16. A history of heterogeneous organ transplantation or a history of heterogeneous hematopoietic stem cell transplantation;
17. Traditional Chinese medicine decoction pieces or proprietary Chinese patent medicine that have received anti-tumor treatment within 7 days before randomly entering the group;
18. Persons prone to bleeding or undergoing thrombolytic or anticoagulant therapy (except for maintaining venous catheter);
19. Those who have been vaccinated within 3 months before signing the informed consent, or who intend to be vaccinated during the study period;
20. Those who had a history of blood donation within 3 months before signing the informed consent, or planned to donate blood during the trial period;
21. Subjects who need to receive corticosteroids (methylprednisolone > 10 mg / day or equivalent dose of other similar drugs) or other immunosuppressants for more than 7 days due to certain conditions within 14 days before randomization, except inhaled corticosteroids;
22. HIV antibody, HCV antibody and TP antibody were positive; Hepatitis B surface antigen positive or hepatitis B core antibody positive patients need further hepatitis B virus DNA detection. If the upper limit of the hospital's reference value is greater than or equal to that of the hospital, we need to exclude it.
23. Patients with diseases affecting intravenous injection and blood collection at present;
24. Those who plan to donate sperm within 6 months from the signing of informed consent to the last administration of experimental drugs;
25. There are known or suspected cases of not being able to comply with the study protocol (for example, alcoholism, drug dependence or mental disorder), or according to the opinion of the researcher, it may increase the risk of subjects participating in the study; Or there are diseases that researchers believe that participating in the study is not their best choice (for example, damaging health) or affect, limit or confuse the evaluation of the study protocol;
26. The researcher thinks that it is not suitable for inclusion or may not be able to complete this trial for other reasons.

研究实施时间：

Study execute time：

从 From 2021-06-18 00:00:00至 To 2026-06-25 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-08-04 00:00:00 至 To 2023-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

150

Group：

Treatment group

Sample size：

干预措施：

静脉滴注BR101注射液单次给药观察28天后每周给药1次，直至受试者出现不可接受的毒性、疾病进展、受试者依从性不佳、怀孕、撤回知情、死亡、研究中断、退出研究。

干预措施代码：

Intervention：

BR101 injection was administered once for 28 days observation period and then weekly until the subject experienced unacceptable toxicity, disease progression, poor compliance, pregnancy, informed withdrawal, death, study interruption, and withdrawal from the study.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

 杭州 

Country：

China 

Province：

Zhejiang 

City：

Hangzhou 

单位(医院)：

浙江大学医学院附属第二医院 

单位级别：

三级甲等 

Institution
hospital：

The Second Affiliated Hospital of Zhejiang University Medical College

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

基于NCI CTCAE 5.0版标准评价的DLT、各类不良事件发生率和严重程度，异常体格检查、生命体征、实验室检查、12导联心电图等；最大耐受剂量（MTD）。

指标类型：

主要指标

Outcome：

The incidence and severity of various adverse events of DLT, evaluated per NCI CTCAE 5.0 standard, abnormal physical examination, vital signs, laboratory examination, 12-guided ECG, etc.; maximum tolerated dose (MTD).

Type：

Primary indicator

测量时间点：

单次给药后28天

测量方法：

体格检查、生命体征、实验室检查、12导联心电图、不良事件（AE）及免疫相关不良事件（irAE）

Measure time point of outcome：

28 days after a single administration

Measure method：

Physical examination, vital signs, laboratory examination, 12-guided ECG, adverse events (AE), and immune-related adverse events (irAE)

指标中文名：

II期临床试验推荐剂量（RP2D）

指标类型：

主要指标

Outcome：

Recommended Phase II clinical trial dose (RP2D)

Type：

Primary indicator

测量时间点：

Ia阶段结束后

测量方法：

体格检查、生命体征、实验室检查、12导联心电图、不良事件（AE）及免疫相关不良事件（irAE）

Measure time point of outcome：

After stage Ia

Measure method：

Physical examination, vital signs, laboratory examination, 12-guided ECG, adverse events (AE), and immune-related adverse events (irAE)

指标中文名：

药代动力学评估

指标类型：

次要指标

Outcome：

Pharmacokinetic Assessment

Type：

Secondary indicator

测量时间点：

至末次给药后720 h±72 h（D31）

测量方法：

血液

Measure time point of outcome：

Up to 720 h after the last Administration +/-72 h (D31)

Measure method：

Blood

指标中文名：

免疫原性评估

指标类型：

次要指标

Outcome：

Immunogenicity assessment

Type：

Secondary indicator

测量时间点：

至末次给药后720 h±72 h（D31）

测量方法：

血液

Measure time point of outcome：

Up to 720 h after the last Administration +/-72 h (D31)

Measure method：

Blood

指标中文名：

疗效评估

指标类型：

次要指标

Outcome：

Efficacy assessment

Type：

Secondary indicator

测量时间点：

C0D29（±1天）及C1D1后每6周（±2天）1次

测量方法：

CT、MR

Measure time point of outcome：

C0D29 (+/- 1 day) and every 6 weeks after c1d1 (+/- 2 days)

Measure method：

CT, MR

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

病理组织切片

组织：

Sample Name：

Pathological section

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

NA

Randomization Procedure (please state who generates the random number sequence and by what method)：

NA

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

N/A

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

原始数据不公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Raw data is not public

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

本研究采用电子病例报告表（eCRF），eCRF 是一个经验证的、符合所有法规要求的数据管理系统，内容将由研究者或受其委派并经过培训的人员通过临床电子数据采集与管理系统（EDC）填写。研究开始前eCRF在EDC系统内设置完毕，并分配给各个研究中心负责填写eCRF表的研究者和/或其授权人员每人一个账号，申办方将向研究中心提供关于相应eCRF 填写的培训和帮助文本。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

This study uses the Electronic Case Report Form (eCRF), a proven data management system meeting all regulatory requirements that will be completed by researchers or their assigned and trained personnel through the Clinical Electronic Data Acquisition and Management System (EDC). eCRF has been set in the EDC system before the study and assigned to the investigator and / or its authorized person to fill out the eCRF form, and the sponsor will provide the research center with training and assistance text on the corresponding eCRF.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-07-19 21:54:40