ChiCTR2600116872 版本V1.0 版本创建时间2026/01/15 17:57:03 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：

ChiCTR2600116872 

最近更新日期：

Date of Last Refreshed on：

2026-01-15 17:56:37 

注册时间：

Date of Registration：

2026-01-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

阿得贝利单抗联合化疗及脑部放疗一线治疗伴脑转移 ES-SCLC 的前瞻性临床研究

Public title：

A prospective clinical study of Adebrelimab combined with chemotherapy and brain radiotherapy as the first-line treatment for extensive-stage small cell lung cancer with brain metastases

注册题目简写：

English Acronym：

研究课题的正式科学名称：

阿得贝利单抗联合化疗及脑部放疗一线治疗伴脑转移 ES-SCLC 的前瞻性临床研究

Scientific title：

A prospective clinical study of Adebrelimab combined with chemotherapy and brain radiotherapy as the first-line treatment for extensive-stage small cell lung cancer with brain metastases

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：

陈利娟 

研究负责人：

陈利娟 

Applicant：

Lijuan Chen 

Study leader：

Chen Lijuan 

申请注册联系人电话：

Applicant telephone：

+86 371 65587657

研究负责人电话：

Study leader's telephone：

+86 13837174273

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：

ljhappy8888@163.com

研究负责人电子邮件：

Study leader's E-mail：

ljhappy8888@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：

河南省郑州市东明路127号

研究负责人通讯地址：

河南省郑州市东明路127号

Applicant address：

127 Dongming Road, Zhengzhou City, Henan Province

Study leader's address：

127 Dongming Road, Zhengzhou City, Henan Province

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：

河南省肿瘤医院

Applicant's institution：

Henan Cancer Hospital

研究负责人所在单位：

河南省肿瘤医院

Affiliation of the Leader：

Henan Cancer 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：

2025-659

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：

河南省肿瘤医院医学伦理委员会（第三伦理委员会）

Name of the ethic committee：

Henan Cancer Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-29 00:00:00

伦理委员会联系人：

方可可

Contact Name of the ethic committee：

Fang KeKe

伦理委员会联系地址：

河南省郑州市东明路127号

Contact Address of the ethic committee：

127 Dongming Road, Zhengzhou City, Henan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 371 65588251

伦理委员会联系人邮箱：

Contact email of the ethic committee：

Kafka_610@163.com

研究实施负责（组长）单位：

河南省肿瘤医院

Primary sponsor：

Henan Cancer Hospital

研究实施负责（组长）单位地址：

河南省郑州市东明路127号

Primary sponsor's address：

127 Dongming Road, Zhengzhou City, Henan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河南省

市(区县)：

Country：

China

Province：

Henan

City：

单位(医院)：

河南省肿瘤医院

具体地址：

河南省郑州市东明路127号

Institution
hospital：

Henan Cancer Hospital

Address：

127 Dongming Road, Zhengzhou City, Henan Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Soure of funding

Target disease：

Extensive-stage small-cell lung cancer with brain metastasis

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

单臂 

Study design：

Single arm 

研究目的：

探索阿得贝利单抗联合化疗及脑部放疗一线治疗ES-SCLC的有效性和安全性  

Objectives of Study：

Exploration of the Efficacy and Safety of Adebrelimab Combined with Chemotherapy and Brain Radiotherapy in the First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)

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. 自愿加入本研究并签署知情同意书（Inform consent form，ICF）；
2. 年龄≥18周岁，男女不限；
3. 组织学或细胞学证实的ES-SCLC（根据美国退伍军人肺癌协会（VALG） 的二期分期法和AJCC TNM分期方法结合：广泛期：AJCC（第8版）Ⅳ期 （任何T,任何N，M1a/b/c）或者T3-4由于肺部多发结节或者肿瘤/结节体积过大而不能被包含在一个可耐受的放疗计划中）；
4. ECOG PS：0-1；
5. 既往未接受过针对ES-SCLC的一线全身系统性治疗；
6. 入组前4周内，经影像学确定存在脑转移，个数不限，颅内病灶最大直径≥ 0.5cm，允许伴有临床症状的脑转移（要求：颅内高压通过脱水治疗症状可 以控制，距离放疗开始≥3天症状未进一步加剧；地塞米松治疗要求≤ 10mg/d）；
7. 依据RECIST 1.1标准，颅外至少有一个可测量的靶病灶；
8. 预期生存期≥12周；
9. 重要器官的功能符合下列要求： （1）血常规：白细胞计数（WBC）≥3.0×10^9 /L；绝对中性粒细胞计数（ANC） ≥1.5×10^9 /L；血小板（PLT）≥100×10^9 /L；血红蛋白含量（HGB）≥9.0 g/dL （14日内无相应的输血、升白细胞等支持治疗）； （2）肝功能：无肝转移患者天门冬氨酸氨基转移酶（AST）、丙氨酸氨基 转移酶（ALT）≤2.5xULN，肝转移患者其ALT和AST≤5xULN；血清 总胆红素（TBIL）≤1.5xULN (除外Gilbert 综合征总胆红素＜3.0 mg/dL)； 白蛋白（ALB）≥30g/L，碱性磷酸酶（ALP）≤2.5×ULN，骨转移患者， ALP≤5×ULN； （3）肾功能：血清肌酐≤1.5xULN 或肌酐清除率 (CrCl) ≥50 mL/min (使 用 Cockcroft/Gault 公式) ；尿蛋白（UPRO）＜(++)，或 24 小时尿蛋白 量＜1.0 g； （4）凝血功能：国际标准化比率（INR）≤1.5且活化部分凝血活酶时间 （APTT）≤1.5xULN；若患者正在接受抗凝治疗，则只要PT或APTT在预期使用抗凝剂的治疗范围内，具体参考相关药物说明书； （5）其他：脂肪酶≤1.5 x ULN。若脂肪酶>1.5 x ULN无临床或影像学证实胰腺炎的情况可以入组；
10. 非手术绝育或育龄期女性患者必须在首次用药前7天内进行血清妊娠试验， 且结果为阴性；且必须为非哺乳期。育龄期女性患者或伴侣为育龄期女性 的男性患者必须同意在研究期间和末次给予研究药物后6个月内采用高效 方法避孕。

Inclusion criteria

1. Voluntarily participate in this study and sign the informed consent form (ICF); 2. Aged 18 years or older, with no restriction on gender; 3. Histological or cytological confirmation of ES-SCLC (based on the second-stage staging method of the Veterans Lung Cancer Association (VALG) and the AJCC TNM staging method combined: Extensive stage: AJCC (8th edition) stage IV (any T, any N, M1a/b/c) or T3-4 due to multiple pulmonary nodules or large tumor/lesion volume that cannot be included in an acceptable radiotherapy plan); 4. ECOG PS:0-1; 5. Has not received any first-line systemic treatment for ES-SCLC in the past; 6. Within 4 weeks prior to enrollment, brain metastases were confirmed by imaging, with no limit on the number of metastases. The maximum diameter of the intracranial lesions was >= 0.5 cm. Brain metastases with clinical symptoms were allowed (requirements: intracranial hypertension could be controlled by dehydration treatment, and the symptoms did not further worsen within >= 3 days after the start of radiotherapy; dexamethasone treatment required <= 10 mg/day). 7. According to the RECIST 1.1 standard, there must be at least one measurable target lesion outside the brain. 8. Expected survival period >= 12 weeks; 9. The functions of the vital organs should meet the following requirements: (1) Blood routine: White blood cell count (WBC) >= 3.0×10^9 /L; Absolute neutrophil count (ANC) >= 1.5×10^9 /L; Platelet count (PLT) >= 100×10^9 /L; Hemoglobin content (HGB) >= 9.0 g/dL (without corresponding blood transfusion, white blood cell elevation, etc. within 14 days); (2) Liver function: For patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5xULN; For patients with liver metastasis, their ALT and AST <= 5xULN; Serum total bilirubin (TBIL) <= 1.5xULN (excluding Gilbert syndrome with total bilirubin < 3.0 mg/dL); Albumin (ALB) >= 30g/L, alkaline phosphatase (ALP) <= 2.5×ULN, for patients with bone metastasis, ALP <= 5×ULN; (3) Kidney function: Serum creatinine <= 1.5xULN or creatinine clearance rate (CrCl) >= 50 mL/min (using Cockcroft/Gault formula); Urine protein (UPRO) < (++) or 24-hour urine protein volume < 1.0 g; (4) Coagulation function: International normalized ratio (INR) <= 1.5 and activated partial thromboplastin time (APTT) <= 1.5xULN; If the patient is receiving anticoagulation treatment, as long as PT or APTT is within the expected range for using the anticoagulant, refer to the relevant drug instructions; (5) Other: Lipase <= 1.5 x ULN. If the lipase > 1.5 x ULN and there is no clinical or imaging evidence of pancreatitis, the patient can be enrolled. 10. For non-surgical sterilization or women of childbearing age, a serum pregnancy test must be conducted 7 days prior to the first administration of the drug, and the result must be negative; and they must be non-lactating. Male patients whose partner or the patient themselves is of childbearing age must agree to use an effective method of contraception during the study period and for the next 6 months after the last administration of the study drug.

排除标准：

1. 既往接受过任何T细胞共刺激或免疫检查点治疗，包括但不限于细胞毒性T 淋巴细胞相关抗原-4（CTLA-4）抑制剂、PD-1抑制剂、PD-L1抑制剂、CD137 激动剂或其他靶向T细胞的药物。
2. 既往曾针对局限期SCLC接受放化疗的患者、针对脑部PCI患者；
3. 有临床症状的软脑膜转移的受试者；
4. 肿瘤组织学或细胞学病理证实合并非小细胞肺癌、大细胞神经内分泌癌成分或肉瘤样病变；
5. 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、皮质类 固醇或免疫抑制剂）的活动性自身性免疫疾病或有自身免疫病病史且预期 复发。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 的生理性皮质类固醇等）不视为全身性治疗；
6. 诊断为免疫缺陷或研究首次给药前14天内正在接受全身性糖皮质激素治疗或任何其他形式的免疫抑制疗法；允许使用生理剂量的糖皮质激素（≤10 mg/天的强的松或等效药物）；
7. 首次给药前6个月内发生过动/静脉血栓事件，如脑血管意外（包括暂时性 缺血性发作、脑出血、脑栓塞等）、深静脉血栓及肺栓塞者；
8. 有特发性肺纤维化、机化性肺炎（如闭塞性细支气管炎）、药物性肺炎或特发性肺炎病史，或筛选时的胸部计算机断层扫描（CT）显示存在活动性肺炎证据 （活动性肺结核患者不能入组）；
9. 首次给药前 28 天内接受了重大外科治疗或明显创伤性损伤；
10. 首次给药前4周内接种过或计划接种预防疫苗或减毒活疫苗；
11. 签署ICF前4周内曾接受其它任何试验药物治疗或参加过另一项干预性临床研究；
12. 5年内受试者既往或同时患有其它恶性肿瘤需要积极治疗(已充分治疗的如 预计5年生存期>90%基底细胞或鳞状上皮细胞皮肤癌、宫颈原位癌、根治术后的局部前列腺癌、局限性膀胱癌、根治术后的导管原位癌、原位乳腺癌除外)；
13. 查体和实验室检查所见：存在任何重度和/或未能控制得疾病得受试者，包括： a)有未能良好控制的心脏临床症状或疾病如：患有≥2级心肌缺血或心肌梗塞、不可控制的心律失常（包括男QTc ≥450ms），QTc ≥470ms(女））及≥2级充血性心功能衰竭（纽约心脏病协会（NYHA）分级），不稳定型心绞痛，24周内发生过心肌梗死，有临床意义的室上性或室性心律失常需要治疗或干预）; b) 活动性或未能控制的严重感染(≥CTCAE 2级感染)，包括但不限于因感染并发症、菌血症或严重肺炎住院，首次给药前发生原因不明发热>38.5℃。 c) 肝硬化、活动性肝炎*； *活动性肝炎-乙肝参考：HBsAg阳性，超过正常值上限（1000拷贝数/ml或500 IU/ml）；既往有乙型肝炎病毒(HBV) 感染或已治愈HBV感染的患者(定义为乙肝核心抗体HBcAb存在和HbsAg 不存在,并在筛选期检测HBV DNA值正常者可纳入; *丙肝参考：HCV抗体阳性，且HCV病毒滴度检测值超过正常值上限 /HCV RNA或HCV Ab检测提示急慢性感染； d) HIV检测阳性或已知的获得性免疫缺陷综合征 ； e) 尿常规提示尿蛋白≥2+，且证实24小时尿蛋白定量＞1.0 g者；
14. 有临床症状的第三间隙积液，如经抽水或其他治疗仍无法控制的心包积液、 胸腔积液和需要反复引流的腹腔积液（如每月一次或更频繁）；
15. 先前治疗引起的不良事件（脱发除外）未恢复至≤CTCAE 1级的受试者 ； 其他因既往抗肿瘤治疗导致的毒性预期内不能解决且有长期持续的后遗 症，如铂类为基础的治疗导致的神经毒性，允许入组；
16. 已知异体器官移植史或异体造血干细胞移植史；
17. 具有精神类药物滥用史且无法戒除、有精神障碍、酗酒、吸毒或药物滥用 者 ；
18. 已知对研究药物或辅料过敏，已知对任何一种单抗发生严重过敏反应 ；
19. 经研究者判断，有严重危害受试者安全或有其他可能导致本研究被迫中途 终止的因素，如，不依从方案、其他的严重疾病（含精神疾病）需要合并 治疗，有严重的实验室检查异常或代谢功能障碍，伴有家庭或社会等因素， 会影响到受试者的安全，或资料及样品的收集或影响结果的解释。

Exclusion criteria：

1. Have previously received any T-cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1 inhibitors, CD137 agonists, or other drugs targeting T-cells. 2. Patients who had previously received radiotherapy and chemotherapy for limited-stage small cell lung cancer, and patients with brain metastases from primary cancer; 3. Subjects with clinical symptoms of leptomeningeal metastasis; 4. The tumor was histologically or cytologically confirmed to contain components of non-small cell lung cancer, large cell neuroendocrine carcinoma, or sarcomatous lesions; 5. Within 2 years prior to the first administration, there has been a case of active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants), or a history of autoimmune disease with a predicted recurrence. Alternative therapies (such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment; 6. Diagnosed with immunodeficiency or having received systemic glucocorticoid therapy within 14 days prior to the first administration of the study drug, or undergoing any other form of immunosuppressive therapy; Allowed to use a physiological dose of glucocorticoids (≤ 10mg/day of prednisone or equivalent). 7. Those who have experienced thrombotic events (such as cerebrovascular accidents including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, or pulmonary embolism within 6 months prior to the first administration; 8. Has a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia; or the chest computed tomography (CT) scan at screening shows evidence of active pneumonia (patients with active tuberculosis cannot be enrolled); 9. Within 28 days prior to the first administration, had undergone major surgical treatment or suffered from significant traumatic injury; 10. Within 4 weeks prior to the first administration, had received or planned to receive prophylactic vaccines or attenuated live vaccines; 11. Within the four weeks prior to signing the ICF, had received any other investigational drug treatment or participated in another interventional clinical study; 12. Within 5 years, the subject has a history of or concurrently suffers from other malignant tumors that require active treatment (except for those that have been fully treated with an expected 5-year survival rate > 90%, such as basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, localized prostate cancer after radical resection, localized bladder cancer, ductal carcinoma in situ after radical resection, and carcinoma in situ of the breast). 13. Findings from Physical Examination and Laboratory Tests Subjects with any severe and/or uncontrolled diseases, including:a) Unwell-controlled clinical symptoms or diseases of the heart, such as: >= Grade 2 myocardial ischemia or myocardial infarction, uncontrollable arrhythmia (including QTc >= 450ms in males and QTc >= 470ms in females), >= Grade 2 congestive heart failure (New York Heart Association [NYHA] classification), unstable angina pectoris, myocardial infarction occurring within 24 weeks, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;b) Active or uncontrolled severe infection (>= CTCAE Grade 2 infection), including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia, and unexplained fever > 38.5℃ occurring before the first dose administration;c) Liver cirrhosis, active hepatitis*;*Definition of active hepatitis: For hepatitis B: HBsAg positive with a value exceeding the upper limit of normal (ULN) (1000 copies/mL or 500 IU/mL); Patients with a history of hepatitis B virus (HBV) infection or cured HBV infection (defined as presence of hepatitis B core antibody [HBcAb], absence of HBsAg, and normal HBV DNA level detected during the screening period) may be included; For hepatitis C: HCV antibody positive with HCV viral titer exceeding the ULN, or HCV RNA/HCV Ab test indicating acute or chronic infection; d) Positive HIV test result or known acquired immunodeficiency syndrome (AIDS); e) Urinalysis indicating urine protein >= 2+, and confirmed 24-hour urine protein quantification > 1.0 g. 14. Clinically symptomatic third-space fluid accumulation, such as pericardial effusion and pleural effusion that remain uncontrollable despite fluid aspiration or other treatments, and peritoneal effusion requiring repeated drainage (e.g., once a month or more frequently); 15. Subjects with adverse events caused by previous treatments (except alopecia) that have not resolved to <= CTCAE Grade 1; however, subjects with long-term persistent sequelae of toxicity from prior anti-tumor treatments that are not expected to resolve (e.g., neurotoxicity induced by platinum-based therapy) are permitted to enroll; 16. Having a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. Individuals with a history of substance abuse (such as psychoactive drugs), who are unable to quit, have mental disorders, are alcoholics, drug addicts or substance abusers; 18. Known to be allergic to the study drug or excipients, and known to have experienced a severe allergic reaction to any monoclonal antibody; 19. Based on the researchers' assessment, there are factors that pose a significant threat to the safety of the subjects or that may lead to the premature termination of this study. Such factors include non-compliance with the protocol, the need for combined treatment for other serious diseases (including mental disorders), severe laboratory test abnormalities or metabolic disorders, and factors related to the family or society that could affect the safety of the subjects, or affect the collection of data and samples or the interpretation of results.

研究实施时间：

Study execute time：

从 From 2026-01-30 00:00:00至 To 2028-01-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-30 00:00:00 至 To 2027-01-30 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

28

Group：

Experimental Group

Sample size：

干预措施：

阿得贝利单抗联合化疗及脑部放疗

干预措施代码：

Intervention：

Adebrelimab Combined with Chemotherapy and Brain Radiotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河南省 

市(区县)：

  

Country：

China 

Province：

Henan 

City：

 

单位(医院)：

河南省肿瘤医院 

单位级别：

三级甲等 

Institution
hospital：

Henan Cancer Hospital

Level of the institution：

Tertiary A

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 (PFS)

Type：

Primary indicator

测量时间点：

每2周期

测量方法：

影像学评估

Measure time point of outcome：

Every two cycles

Measure method：

Imaging assessment

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：

每个周期

测量方法：

检验、检查结果及受试者反馈，根据CTCAE 5.0进行分级

Measure time point of outcome：

Every cycle

Measure method：

Test results, inspection outcomes and feedback from the subjects

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

Objective Response Rate, ORR

Type：

Secondary indicator

测量时间点：

每2周期

测量方法：

影像学评估

Measure time point of outcome：

Every two cycles

Measure method：

Imaging assessment

指标中文名：

疾病控制率

指标类型：

次要指标

Outcome：

Disease Control Rate, DCR

Type：

Secondary indicator

测量时间点：

每2周期

测量方法：

影像学评估

Measure time point of outcome：

Every two cycles

Measure method：

Imaging assessment

指标中文名：

颅内病灶的客观缓解率

指标类型：

次要指标

Outcome：

iORR

Type：

Secondary indicator

测量时间点：

每2周期

测量方法：

影像学评估

Measure time point of outcome：

Every two cycles

Measure method：

Imaging assessment

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

Overall Survival, OS

Type：

Secondary indicator

测量时间点：

每2周期

测量方法：

影像学评估

Measure time point of outcome：

Every two cycles

Measure method：

Imaging assessment

指标中文名：

颅内无进展生存期

指标类型：

次要指标

Outcome：

iPFS

Type：

Secondary indicator

测量时间点：

每2周期

测量方法：

影像学评估

Measure time point of outcome：

Every two cycles

Measure method：

Imaging assessment

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血样

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：

组织

组织：

Sample Name：

tissue

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 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：

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）：

NA

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

NA

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：

病例报告表

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-15 17:56:37