中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400089592
最近更新日期： Date of Last Refreshed on：	2024-09-11 14:41:31
注册时间： Date of Registration：	2024-09-11 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	信迪利单抗联合 GS 方案新辅助治疗局部进展期胆道癌（BTC）的 II 期研究
Public title：	Phase II study of Sintilimab combined with GS regimen for neoadjuvant treatment of locally advanced biliary tract cancer (BTC)
注册题目简写：
English Acronym：
研究课题的正式科学名称：	信迪利单抗联合 GS 方案新辅助治疗局部进展期胆道癌（BTC）的 II 期研究
Scientific title：	Phase II study of Sintilimab combined with GS regimen for neoadjuvant treatment of locally advanced biliary tract cancer (BTC)
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：	易滨	研究负责人：	易滨
Applicant：	Bin Yi	Study leader：	Bin Yi
申请注册联系人电话： Applicant telephone：	+86 21 8188 7575	研究负责人电话： Study leader's telephone：	+86 21 8188 7575
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：	billyyi11@163.com	研究负责人电子邮件： Study leader's E-mail：	billyyi11@163.com
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：	上海市嘉定区安亭镇墨玉北路700号	研究负责人通讯地址：	上海市嘉定区安亭镇墨玉北路700号
Applicant address：	No. 700, Moyu North Road, Anting Town, Jiading District, Shanghai	Study leader's address：	No. 700, Moyu North Road, Anting Town, Jiading District, Shanghai
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：	海军军医大学第三附属医院(上海东方肝胆外科医院)
Applicant's institution：	Shanghai Eastern Hepatobiliary Surgery Hospital
研究负责人所在单位：	海军军医大学第三附属医院(上海东方肝胆外科医院)
Affiliation of the Leader：	Shanghai Eastern Hepatobiliary Surgery Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	EHBHKY2024-H005-P001	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：	海军军医大学第三附属医院伦理学委员会
Name of the ethic committee：	Ethics Committee of Shanghai Eastern Hepatobiliary Surgery Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-04-25 00:00:00
伦理委员会联系人：	邰小云
Contact Name of the ethic committee：	Xiaoyun Tai
伦理委员会联系地址：	上海市杨浦区长海路225号
Contact Address of the ethic committee：	No. 225, Changhai Road, Yangpu District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 152 2139 0719	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：

海军军医大学第三附属医院（上海东方肝胆外科医院）

Primary sponsor：

Shanghai Eastern Hepatobiliary Surgery Hospital

研究实施负责（组长）单位地址：

上海市嘉定区安亭镇墨玉北路700号

Primary sponsor's address：

No. 700, Moyu North Road, Anting Town, Jiading District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	海军军医大学第三附属医院（上海东方肝胆外科医院）	具体地址：	上海市嘉定区安亭镇墨玉北路700号
Institution hospital：	Shanghai Eastern Hepatobiliary Surgery Hospital	Address：	No. 700, Moyu North Road, Anting Town, Jiading District, Shanghai

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

胆道癌

Target disease：

biliary tract cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

探索信迪利单抗联合 GS 新辅助治疗BTC 的疗效及安全

Objectives of Study：

To explore the efficacy and safety of sintilimab combined with GS neoadjuvant therapy for BTC

药物成份或治疗方案详述：

术前：信迪利单抗：200 mg 静脉输注（30-60 分钟内）Q3W D1，共 2 周期吉西他滨：1000mg/m2，静脉输注 Q3W D2，D9，共 2 周期替吉奥：40mg(BSA<1.25m2), 50mg(BSA 1.25-1.5m2),60mg (BSA≥1.5m2) BID,每口服 2 周，休息 1 周，Q3W D2-15，共 2 周期；术后（术后 4-6 周开始用药）：信迪利单抗：200 mg 静脉输注（30-60 分钟内）Q3W D1，共 8 周期替吉奥：40mg(BSA<1.25m2), 50mg(BSA 1.25-1.5m2),60mg (BSA≥1.5m2), BID,每口服 2 周，休息 1 周，Q3W D2-15，共 8 周期；

Description for medicine or protocol of treatment in detail：

Preoperatively: Sintilimab: 200 mg intravenous infusion (within 30-60 minutes) Q3W D1 for 2 cycles gemcitabine: 1000mg/m2 intravenous infusion Q3W D2, D9 for 2 cycles S1: 40mg (BSA<1.25m2), 50mg (BSA 1.25-1.5m2), 60mg (BSA≥1.5m2) BID, every 2 weeks orally with 1 week rest, Q3W D2-15, 2 cycles; Postoperatively (starting 4-6 weeks postoperatively): Sintilimab: 200 mg intravenous infusion (within 30-60 minutes) Q3W D1 for 8 cycles S1: 40mg (BSA<1.25m2), 50mg (BSA 1.25-1.5m2), 60mg (BSA≥1.5m2), BID, every 2 weeks orally for 1 week off, Q3W D2-15, for a total of 8 cycles;

纳入标准：

Inclusion criteria

1. Signed written informed consent prior to the implementation of any trial-related procedures
2. Male or female≥ 18 years old, ≤ 75 years old
3. Histologically or cytologically confirmed tumors of the biliary system (including intrahepatic cholangiocarcinoma, gallbladder cancer and extrahepatic cholangiocarcinoma), and the lesions are resectable as assessed by the investigator
4. Preoperative imaging evaluation of the disease stage as AJCC TNM stage III and above non-M1 (among them, the preoperative imaging criteria for lymph node metastasis are: enhanced CT or MRI with enlarged lymph nodes, short diameter ≥ 1.5cm or short diameter ≥1.0cm with enhanced manifestations; or PET-CT, PET-MR has high uptake)
5. No prior systemic anti-tumor therapy (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
6. Expected survival time> 3 months
7. At least 1 measurable lesion according to RECIST1.1 criteria
8. ECOG PS score of 0-1
9. Adequate organ function, subjects need to meet the following laboratory indicators:
1) Absolute neutrophil value (ANC) ≥ 1.5x10^9/L and platelet ≥ 90×10^9/L without granulocyte colony-stimulating factor in the past 14 days;
2) Hemoglobin > 9g/dL in the absence of blood transfusion or erythropoietin use in the past 21 days;
3) Total bilirubin ≤3× upper limit of normal (ULN);
4) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at ≤ 2.5× ULN (patients with liver metastases are allowed ALT or AST ≤5×ULN);
5) Alkaline phosphatase (AKP) ≤2.5×ULN
6) creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 50 ml/min;
7) good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
8) normal thyroid function, defined as thyroid-stimulating hormone (TSH≤10) within the normal range; If there is no clinically significant thyroid dysfunction after thyroid hormone supplementation, they can also be enrolled.
9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll);
10. For female subjects of childbearing potential, a urine or serum pregnancy test with a negative result within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy.
11. If there is a risk of conception, all subjects, male or female, are required to use contraception with an annual failure rate of less than 1% throughout the treatment period and up to 120 days after the last dose of study drug.

排除标准：

1.首次给药前 5 年内诊断为胆道外的其他恶性疾病（不包括经过根治的皮肤基底细胞癌、皮肤鳞状上皮癌、和/或经过根治性切除的原位癌，甲状腺乳头状癌根治术后也可以入组）； 2.当前正在参与干预性临床研究治疗，或在首次给药前 4 周内接受过其他研究药物或使用过研究器械治疗； 3.首次给药前发生过需要全身性治疗（例如使用缓解疾病药物、糖皮质激素或免疫抑制剂）的活动性自身性免疫疾病。替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性糖皮质激素等）不视为全身性治疗。已知的原发性免疫缺陷病史。仅存在自身免疫抗体阳性的患者需根据研究者判断确认是否存在自身免疫性疾病； 4.当前或近期（接受首剂研究药物前 10 天内）连续 10 天使用阿司匹林（>325mg/天）或其他已知可以抑制血小板功能的非甾体抗炎药； 5.当前或近期（接受首剂研究药物前 10 天内）连续 10 天使用全剂量口服或胃肠外抗凝血药或血栓溶解剂进行治疗注：允许预防性使用小剂量抗凝血药：在凝血酶原时间国际标准化比值（INR）≤1.5 的前提下，允许以预防目的使用小剂量华法林（≤1mg/d）小剂量肝素（≤1.2 万 U/d）或小剂量阿司匹林（≤100mg/d）； 6.有遗传性出血倾向或凝血功能障碍，或血栓病史； 7.研究首次给药前 4 周内正在接受全身性糖皮质激素治疗（不包括喷鼻吸入性或其他途径的局部糖皮质激素）或任何其他形式的免疫抑制疗法注：允许使用生理剂量的糖皮质激素（≤10 mg/天的泼尼松或等效药物) 8.存在临床上不可控制的胸腔积液/腹腔积液（不需要引流积液或停止引流 3 天积液无明显增加的患者可以入组） 9.已知异体器官移植（角膜移植除外）或异体造血干细胞移植 10.已知对本研究药物信迪利单抗、注射用盐酸吉西他滨、口服替吉奥活性成分或辅料过敏者 11.在开始治疗前，尚未从任何干预措施引起的毒性和/或并发症中充分恢复（即，≤1 级或达到基线，不包括乏力或脱发） 12.已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2 抗体阳性） 13.未经治疗的活动性乙肝（定义为 HBsAg 阳性同时检测到 HBV-DNA拷贝数大于所在研究中心检验科正常值上限）注：符合下列标准的乙肝受试者亦可入组： 1)首次给药前HBV 病毒载量<2.5×10^3 拷贝/ml（500 IU/ml），受试者应在整个研究治疗期间接受抗 HBV 治疗 2)对于HBcAb（+）、HBsAg（-）、HBsAb（-）和HBV 病毒载量小于所在研究中心检验科正常值上限的受试者，不需要接受预防性抗HBV 治疗，但是需要密切监测病毒再激活 14.活动性的HCV 感染受试者（HCV 抗体阳性且HCV-RNA 水平高于检测下限） 15.首次给药前 4 周内接种过减毒活疫苗，新冠疫苗除外 16.妊娠或哺乳期妇女 17.既往 6 个月内动、静脉血栓栓塞事件，包括心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作、肺动脉栓塞、深静脉血栓或其它任何严重血栓栓塞的病史。植入式静脉输液港或导管源性血栓形成，或浅表静脉血栓形成，经过常规抗凝治疗后血栓稳定者除外 18.存在任何严重或不能控制的全身性疾病，例如： 1)静息心电图在节律、传导或形态上出现有重大且症状严重难以控制的异常，如完全性左束支传导阻滞，Ⅱ度以上心脏传导阻滞，室性心律失常或伴快心室率的心房颤动 2)不稳定型心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级≥ 2 级的慢性心衰 3)在入选治疗前 6 个月内发生过任何动脉血栓、栓塞或缺血，如心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等； 4)首次给药前 4 周之内接受过重大的外科手术（开颅、开胸或开腹手术）或者未愈合的伤口、溃疡或骨折。首次给药之前 7 天内接受过组织穿刺活检或其他小外科手术，以静脉输液为目的的静脉穿刺置管除外 5)血压控制不理想（收缩压＞140 mmHg 和 /或舒张压＞90 mmHg) 6)活动性肺结核 7)存在需要全身性治疗的活动性或未能控制的感染 8)存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻 9)肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎 10)糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L） 11)尿常规提示尿蛋白≥++，且证实 24 小时尿蛋白定量＞1.0 g 者； 12)存在精神障碍且无法配合治疗的患者 19.有可能干扰试验结果、妨碍受试者全程参与研究的病史或疾病证据、治疗或实验室检查值异常，或研究者认为其他不适合入组的情况研究者认为存在其他潜在风险不适合参加本研究

Exclusion criteria：

1.Diagnosed with other malignant diseases other than biliary tract within 5 years before the first administration (excluding cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or carcinoma in situ after radical resection. Patients after radical resection of papillary thyroid carcinoma can also be enrolled). 2.Currently participating in an interventional clinical study treatment, or received other study drugs or used study devices for treatment within 4 weeks before the first administration. 3.Active autoimmune disease that required systemic treatment (such as using disease-modifying drugs, glucocorticoids or immunosuppressants) before the first administration. Replacement therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic treatment. Known history of primary immunodeficiency. Patients with only positive autoimmune antibodies need to confirm whether there is autoimmune disease according to the investigator's judgment. 4.Currently or recently (within 10 days before receiving the first dose of study drug), continuous use of aspirin (>325mg/day) or other known non-steroidal anti-inflammatory drugs that can inhibit platelet function for 10 days. 5.Currently or recently (within 10 days before receiving the first dose of study drug), continuous use of full-dose oral or parenteral anticoagulants or thrombolytics for treatment. Note: Prophylactic use of low-dose anticoagulants is allowed: Under the premise that the international normalized ratio (INR) of prothrombin time is ≤1.5, prophylactic use of low-dose warfarin (≤1mg/day), low-dose heparin (≤12,000 U/day) or low-dose aspirin (≤100mg/day) is allowed. 6.Have hereditary bleeding tendency or coagulation disorders, or history of thrombosis. 7.Receiving systemic glucocorticoid treatment (excluding intranasal inhalation or local glucocorticoids by other routes) or any other form of immunosuppressive therapy within 4 weeks before the first administration of the study. Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent drugs) are allowed. 8.There is clinically uncontrollable pleural effusion/ascites (patients who do not need to drain the effusion or who have no significant increase in the effusion after stopping drainage for 3 days can be enrolled). 9.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 10.Known allergy to the study drugs sintilimab, gemcitabine hydrochloride for injection, or the active ingredients or excipients of tegafur gimeracil oteracil potassium capsules. 11.Before starting treatment, not fully recovered from toxicity and/or complications caused by any intervention (i.e., ≤grade 1 or reaching baseline, excluding fatigue or hair loss). 12.Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibody). 13.Untreated active hepatitis B (defined as positive HBsAg and detection of HBV-DNA copy number greater than the upper limit of normal value of the laboratory of the research center). Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1).Before the first administration, the HBV viral load is <2.5×10^3 copies/ml (500 IU/ml), and the subject should receive anti-HBV treatment during the entire study treatment period. 2).For subjects with HBcAb (+), HBsAg (-), HBsAb (-) and HBV viral load less than the upper limit of normal value of the laboratory of the research center, prophylactic anti-HBV treatment is not required, but close monitoring of virus reactivation is required. 14.Subjects with active HCV infection (positive HCV antibody and HCV-RNA level higher than the detection limit). 15.Received live attenuated vaccines within 4 weeks before the first administration, except for COVID-19 vaccines. 16.Pregnant or lactating women. 17.History of arterial and venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism. Except for implantable venous access ports or catheter-derived thrombosis, or superficial venous thrombosis that is stable after conventional anticoagulation treatment. 18.There is any serious or uncontrollable systemic disease, such as: 1).Significant and severely symptomatic and difficult-to-control abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, cardiac conduction block above grade II, ventricular arrhythmia or atrial fibrillation with a rapid ventricular rate. 2).Unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) grade ≥ 2. 3).Any arterial thrombosis, embolism or ischemia occurred within 6 months before enrollment in treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, etc.; 4).Received major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks before the first administration, or unhealed wounds, ulcers or fractures. Received tissue biopsy or other minor surgeries within 7 days before the first administration, except for venous catheterization for intravenous infusion. 5).Uncontrolled blood pressure (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg). 6).Active tuberculosis. 7).There is active or uncontrolled infection that requires systemic treatment. 8).There is clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction. 9).Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis. 10).Poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L). 11).Urine routine suggests urine protein ≥++, and it is confirmed that 24-hour urine protein quantification > 1.0 g; 12).Patients with mental disorders and unable to cooperate with treatment. 19.There is evidence of medical history or disease, abnormal treatment or laboratory test values that may interfere with the test results and prevent the subject from participating in the study throughout the whole process, or other situations that the investigator deems inappropriate for enrollment. The investigator deems that there are other potential risks and is not suitable for participating in this study.

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2028-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-10-01 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：	新辅助组	样本量：	38
Group：	Neoadjvant Group	Sample size：	38
干预措施：	新辅助治疗：GS+PD-1方案，3周/周期，2个周期；联合辅助治疗：S1+PD-1方案，3周/周期，8个周期	干预措施代码：
Intervention：	Neoadjuvant therapy: GS+PD-1 regimen, 3 weeks/cycle, 2 cycles; Combined adjuvant therapy: S1+PD-1 regimen, 3 weeks/cycle, 8 cycles	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	海军军医大学第三附属医院（上海东方肝胆外科医院）	单位级别：	三甲
Institution hospital：	Shanghai Eastern Hepatobiliary Surgery Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	1年无复发生存率	指标类型：	主要指标
Outcome：	1-year Relapse-free survival rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	客观缓解率	指标类型：	次要指标
Outcome：	Objective response rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病控制率	指标类型：	次要指标
Outcome：	Disease control rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	术后无复发生存期	指标类型：	次要指标
Outcome：	Relapse-free survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存时间	指标类型：	次要指标
Outcome：	Overall survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	临床降期率	指标类型：	次要指标
Outcome：	Clinical downstage rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	主要病理缓解率	指标类型：	次要指标
Outcome：	Major pathological response rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	病理完全缓解率	指标类型：	次要指标
Outcome：	pathological complete response rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	R0/R1切除率	指标类型：	次要指标
Outcome：	R0/R1 resection rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性	指标类型：	次要指标
Outcome：	safety	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	肿瘤组织	组织：	胆道癌原发部位或转移部位
Sample Name：	tumor tissue	Tissue：	Primary site or metastatic site of biliary tract cancer
人体标本去向	使用后保存	说明	医院常规长期保存
Fate of sample：	Preservation after use	Note：	Regular hospital long-term storage

标本中文名：	血液	组织：	外周血
Sample Name：	Blood	Tissue：	Peripheral blood
人体标本去向	使用后销毁	说明	完成多组学检测后6个月内销毁
Fate of sample：	Destruction after use	Note：	Destroyed within 6 months after completion of multi-omics testing

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	18	岁 years
最大 Max age	75	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）：

无

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

None

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：
Blinding：

是否共享原始数据： IPD sharing	否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）：	向项目负责人申请获得数据使用权限.
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Apply to the project conductor for data usage permissions.
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：	数据由病例记录表保存
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data are saved through case record forms.
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2024-09-11 14:39:42