ChiCTR2500098697 版本V1.0 版本创建时间2025/03/12 15:38:06 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：

ChiCTR2500098697 

最近更新日期：

Date of Last Refreshed on：

2025-03-12 15:37:54 

注册时间：

Date of Registration：

2025-03-12 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

信迪利单抗联合放化疗对比信迪利单抗联合化疗一线治疗术后复发或转移性胆管癌的疗效和安全性的探索性研究

Public title：

An exploratory study of the efficacy and safety of Sintilimab in combination with chemoradiotherapy versus Sintilimab in combination with chemotherapy in the first-line treatment of postoperative recurrent or metastatic cholangiocarcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

信迪利单抗联合放化疗对比信迪利单抗联合化疗一线治疗术后复发或转移性胆管癌的疗效和安全性的探索性研究

Scientific title：

An exploratory study of the efficacy and safety of Sintilimab in combination with chemoradiotherapy versus Sintilimab in combination with chemotherapy in the first-line treatment of postoperative recurrent or metastatic cholangiocarcinoma

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：

王强 

研究负责人：

王强;贾明光 

Applicant：

Wang Qiang 

Study leader：

Wang Qiang, Jia Mingguang 

申请注册联系人电话：

Applicant telephone：

+86 176 6029 2226

研究负责人电话：

Study leader's telephone：

+86 176 6029 2226

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：

1102476752@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1102476752@qq.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：

山东省淄博市临淄区桓公路139号淄博市市立医院

研究负责人通讯地址：

山东省淄博市临淄区桓公路139号淄博市市立医院

Applicant address：

Zibo Municipal Hospital, 139 Huangong Road, Linzi District, Zibo, Shandong

Study leader's address：

Zibo Municipal Hospital, 139 Huangong Road, Linzi District, Zibo, Shandong

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：

淄博市市立医院

Applicant's institution：

Zibo Municipal Hospital

研究负责人所在单位：

淄博市市立医院

Affiliation of the Leader：

Zibo Municipal Hospital

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：

2024-科研-伦理审查-01

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：

淄博市市立医院药物临床试验伦理委员会

Name of the ethic committee：

Drug Clinical Trial Ethics Committee of Zibo Municipal Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-03-02 00:00:00

伦理委员会联系人：

李华

Contact Name of the ethic committee：

Li Hua

伦理委员会联系地址：

山东省淄博市临淄区桓公路139号淄博市市立医院

Contact Address of the ethic committee：

139 Huangong Road, Linzi District, Zibo, Shandong

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 176 6029 2282

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：

淄博市市立医院

Primary sponsor：

Zibo Municipal Hospital

研究实施负责（组长）单位地址：

山东省淄博市临淄区桓公路139号淄博市市立医院

Primary sponsor's address：

139 Huangong Road, Linzi District, Zibo, Shandong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东省

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

淄博市市立医院

具体地址：

山东省淄博市临淄区桓公路139号淄博市市立医院

Institution
hospital：

Zibo Municipal Hospital

Address：

139 Huangong Road, Linzi District, Zibo, Shandong

经费或物资来源：

信达生物制药（苏州）有限公司

Source(s) of funding：

Xinda Biopharmaceuticals (Suzhou) Co., Ltd.

Target disease：

Cholangiocarcinoma

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评估信迪利单抗联合放化疗对比信迪利单抗联合化疗一线治疗术后复发或转移性胆管癌的疗效和安全性。  

Objectives of Study：

To assess the efficacy and safety of sintilimab plus chemoradiotherapy compared with sintilimab plus chemotherapy in the first-line treatment of recurrent or metastatic cholangiocarcinoma.

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.在任何试验相关流程实施之前，签署书面知情同意； 2.男或女性＞＝18周岁，＜＝75周岁； 3.根据UICC/AJCC分期系统（2017年第 8 版）胆管癌TNM分期，经组织学或细胞学证实的胆管癌； 4.既往未接受过系统性治疗，术后辅助治疗结束6个月以上允许入组； 5.预期生存时间>3个月； 6.根据RECIST1.1标准至少有1个可测量病灶； 7.ECOG PS评分为0-1； 8.足够器官功能，受试者需满足如下实验室指标： 1)近14天未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对值（ANC）＞＝1.5x10^9/L； 2)近14天未输血的情况下，血小板＞＝90×10^9/L； 3)近14天内无输血或使用促红细胞生成素的情况下，血红蛋白>9g/dL； 4)总胆红素＜＝1.5×正常值上限（ULN）； 5)天门冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）在＜＝2.5×ULN（有肝转移的患者允许ALT 或AST ＜＝5×ULN）； 6)血肌酐＜＝1.5×ULN并且肌酐清除率（采用Cockcroft-Gault 公式计算）＞＝60 ml/min； 7)凝血功能良好，定义为国际标准化比值（INR）或凝血酶原时间（PT）＜＝1.5倍ULN； 8)甲状腺功能正常，定义为促甲状腺激素（TSH）在正常范围内。如基线TSH超出正常范围，如果总T3（或FT3）及FT4在正常范围内的受试者亦可入组； 9)心肌酶谱在正常范围内（如研究者综合判断为不具有临床意义的单纯实验室异常也允许入组）； 9.有症状的脑转移患者允许入组； 10.对于育龄期女性受试者，应在接受首次研究药物给药（第1周期第1天）之前的3天内接受尿液或血清妊娠试验且结果为阴性。如果尿液妊娠试验结果无法确认为阴性，则要求进行血液妊娠试验。非育龄期女性定义为绝经后至少１年，或进行过手术绝育或子宫切除术； 11.如存在受孕风险，所有受试者（不论男性或女性）均需在整个治疗期间直至治疗末次研究药物给药后120天内采用年失败率低于1%的避孕措施。

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 cholangiocarcinoma according to the TNM staging of cholangiocarcinoma according to the UICC/AJCC staging system (8th edition, 2017); 4. Those who have not received systemic therapy in the past and are allowed to be enrolled more than 6 months after the end of postoperative adjuvant therapy; 5. Expected survival time> 3 months; 6. At least 1 measurable lesion according to RECIST1.1 criteria; 7. ECOG PS score of 0-1; 8. Adequate organ function, subjects need to meet the following laboratory indicators: 1) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) was >=1.5x10^9/L; 2) In the case of no blood transfusion in the past 14 days, platelet >=90×10^9/L; 3) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; 4) Total bilirubin <=1.5× upper limit of normal (ULN); 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in <=2.5×ULN (ALT or AST <=5×ULN is allowed in patients with liver metastases); 6) Serum creatinine <=1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) >=60 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) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range 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); 9. Patients with symptomatic brain metastases are allowed to enroll; 10. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If the 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 until 120 days after the last dose of study drug.

排除标准：

受试者不能有以下的任何排除标准： 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）； 2.肿瘤组织学或细胞学病理证实合并神经内分泌等其它成分； 3.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； 4.既往接受过下列疗法：抗PD-1、抗PD-L1或抗PD-L2药物或者针对另一种刺激或协同抑制T细胞受体（例如，CTLA-4、OX-40、CD137）的药物； 5.既往接受过针对胆道肿瘤姑息性放疗或术后辅助放疗射野内复发者； 6.首次给药前2周内接受过具有抗肿瘤适应症的中成药或免疫调节作用的药物（包括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）系统性全身治疗； 7.首次给药前2年内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； 8.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）； 9.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）； 10.已知异体器官移植（角膜移植除外）或异体造血干细胞移植； 11.已知对本研究药物信迪利单抗活性成分或辅料过敏者； 12.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）； 13.已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）； 14.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)对于抗HBc（+）、HBsAg（-）、抗HBs（-）和HBV病毒载量（-）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； 15.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）； 16.首次给药前4周内接种过减毒活疫苗； 17.妊娠或哺乳期妇女； 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，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：

Subjects must not have any of the following exclusion criteria: 1. Diagnosis of other malignant diseases outside the biliary tract within 5 years before the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Histological or cytopathological confirmation of tumor combined with neuroendocrine and other components; 3. Current participation in interventional clinical study treatment, or treatment with other investigational drugs or investigational devices within 4 weeks prior to the first dose; 4. Prior treatment with the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors (e.g., CTLA-4, OX-40, CD137); 5. Those who have previously received palliative radiotherapy or postoperative adjuvant radiotherapy for biliary tract tumors; 6. Received systemic therapy with anti-tumor indications or immunomodulatory drugs (including thymus peptide, interferon, interleukin, except for topical use for the control of pleural effusion) within 2 weeks before the first dose; 7. Active autoimmune disease requiring systemic treatment (such as use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy. Known history of primary immunodeficiency. Patients with only positive autoimmune antibodies need to confirm the presence of autoimmune disease at the discretion of the investigator; 8. Systemic glucocorticoid therapy (excluding nasal, inhaled, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 4 weeks prior to the first dose of the study; Note: Physiologic doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) are allowed; 9. Presence of clinically uncontrollable pleural effusion/ascites effusion (patients who do not need to drain the effusion or stop draining for 3 days without significant increase in effusion can be enrolled); 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. Those who are known to be allergic to the active ingredient or excipient of the drug sintilimab in this study; 12. Have not recovered adequately from toxicity and/or complications caused by any of the interventions prior to initiation of treatment (i.e., < = Grade 1 or at baseline, excluding fatigue or alopecia); 13. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 14. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected at the same time greater than the upper limit of normal in the laboratory of the research center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: 1) HBV viral load <2.5×10^3 copies/ml (500 IU/ml) before the first dose, and subjects should receive anti-HBV therapy throughout the study treatment period; 2) for subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral loads (-), prophylactic anti-HBV therapy is not required, but viral reactivation needs to be closely monitored; 15. Subjects with active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection); 16. Received live attenuated vaccine within 4 weeks before the first dose; 17. Pregnant or lactating women; 18. Presence of any serious or uncontrollable systemic disease, such as: 1) Resting ECG has major abnormalities in rhythm, conduction or morphology and the symptoms are severe and difficult to control, such as complete left bundle branch block, heart block above the second degree, ventricular arrhythmia or atrial fibrillation; 2) unstable angina, congestive heart failure, New York Heart Association (NYHA) grade >= grade 2 chronic heart failure; 3) Any arterial thrombosis, embolism or ischemia within 6 months prior to the selection of treatment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, etc.; 4) Received major surgical surgery (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks before the first dose. Tissue biopsy or other minor surgical procedures within 7 days prior to the first dose, except for venipuncture catheterization for the purpose of intravenous infusion; 5) unsatisfactory blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 6) active tuberculosis; 7) Presence of active or uncontrolled infection requiring systemic therapy; 8) Presence of 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 mellitus (fasting blood glucose (FBG) >10mmol/L); 11) Those whose urine routine showed that urine protein was >=++, and confirmed that the 24-hour urine protein was > 1.0 g; 12) Patients with mental disorders who are unable to cooperate with treatment; 19. Abnormal medical history or evidence of disease, treatment or laboratory test values that may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or other situations that the investigator considers unsuitable for enrollment in the opinion of the investigator and are not suitable for participating in this study.

研究实施时间：

Study execute time：

从 From 2024-03-01 00:00:00至 To 2027-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-04-02 00:00:00 至 To 2027-02-28 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

20

Group：

Test group

Sample size：

干预措施：

信迪利单抗，200mg， D1给药，21天重复；研究者选择的化疗方案，每21天为一个周期，共用药4-6周期。后给与原发病灶和/或转移病灶放射治疗，完全缓解、部分缓解或疾病稳定的患者，接受维持治疗：信迪利单抗，200mg，D1，21天重复。

干预措施代码：

Intervention：

Sintilimab, 200 mg, D1 administration, repeat at 21 days; The chemotherapy regimen selected by the investigator is a cycle every 21 days, with a total of 4-6 cycles. Patients who are given radiation therapy to the primary and/or metastatic lesions, and who are in complete remission, partially remission, or stable disease, receive maintenance therapy: sintilimab, 200 mg, D1, repeat on 21 days.

Intervention code：

组别：

对照组

样本量：

20

Group：

Control group

Sample size：

干预措施：

信迪利单抗，200mg， D1给药，21天重复；研究者选择的化疗方案，每21天为一个周期，共用药4-6周期。维持治疗信迪利单抗，200mg，D1，21天重复。

干预措施代码：

Intervention：

Sintilimab, 200 mg, D1 administration, repeat at 21 days; The chemotherapy regimen selected by the investigator is a cycle every 21 days, with a total of 4-6 cycles. Maintenance therapy sintilimab, 200 mg, D1, repeated on 21 days.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

  

Country：

China 

Province：

Shandong 

City：

 

单位(医院)：

淄博市市立医院 

单位级别：

三级 

Institution
hospital：

Zibo Municipal Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

无进展生存期

指标类型：

主要指标

Outcome：

Progression-free survival

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：

持续缓解时间

指标类型：

次要指标

Outcome：

Duration of remission

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无进展生存期

指标类型：

次要指标

Outcome：

Progression 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：

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：

指标中文名：

总生存期

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：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织

组织：

胆管、肝脏、肺或淋巴结

Sample Name：

Tissue

Tissue：

Bile ducts, liver, lungs or lymph nodes

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

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）：

应用SPSS软件获得随机数字，编制随机数字卡片，使用不透光信封密封（信封上编上号码），将合格受试者按照纳入顺序选择对应编号的信封，并按照信封内的卡片上的随机数字进行分组。

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

SPSS software is used to obtain random numbers, random number cards are prepared, sealed with opaque envelopes (numbered on the envelopes), eligible subjects are selected according to the inclusion order, and grouped according to the random numbers on the cards in the envelopes.

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：

无

Blinding：

None

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）：

在发表研究结果后的6个月内公开，http://www.medresman.org.cn/login.aspx。

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

Published within 6 months of publication of the results of the study, http://www.medresman.org.cn/login.aspx.

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：

1.病例记录表； 2.电子采集和管理系统

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

Case Record Form; Electronic Data Capture.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-03-12 15:37:54