ChiCTR2500102571 版本V1.0 版本创建时间2025/05/16 09:19:22 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：

 ChiCTR2500102571 

最近更新日期：

Date of Last Refreshed on：

 2025-05-16 09:19:05 

注册时间：

Date of Registration：

 2025-05-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

阿得贝利单抗联合甲磺酸伏美替尼一线治疗PD-L1高表达且EGFR敏感突变晚期非小细胞肺癌单臂、探索性研究

Public title：

A Single-Arm, Exploratory Study of Adebrelimab Combined with Furmonertinib as First-Line Treatment for Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression and Sensitive EGFR Mutationsre

注册题目简写：

BRIGHT-STAR

English Acronym：

BRIGHT-STAR

研究课题的正式科学名称：

阿得贝利单抗联合甲磺酸伏美替尼一线治疗PD-L1高表达且EGFR敏感突变晚期非小细胞肺癌单臂、探索性研究

Scientific title：

A Single-Arm, Exploratory Study of Adebrelimab Combined with Furmonertinib as First-Line Treatment for Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression and Sensitive EGFR Mutationsre

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：

孟祥姣 

研究负责人：

孟祥姣 

Applicant：

Meng Xiangjiao 

Study leader：

Meng Xiangjiao 

申请注册联系人电话：

Applicant telephone：

 +86 137 9315 0996

研究负责人电话：

Study leader's
telephone：

+86 137 9315 0996

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：

 mengxiangjiao@126.com

研究负责人电子邮件：

Study leader's E-mail：

 mengxiangjiao@126.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：

山东省济南市槐荫区济充路440号 No. 440, Jichong Road, Huaiyin District, Jinan City, Shandong Province

研究负责人通讯地址：

山东省济南市槐荫区济充路440号 No. 440, Jichong Road, Huaiyin District, Jinan City, Shandong Province

Applicant address：

440 No. 440, Jichong Road, Huaiyin District, Jinan City, Shandong Province

Study leader's address：

No. 440, Jichong Road, Huaiyin District, Jinan City, Shandong 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：

山东第一医科大学附属肿瘤医院(山东省肿瘤医院)

Applicant's institution：

Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer Hospital)

研究负责人所在单位：

山东第一医科大学附属肿瘤医院(山东省肿瘤医院)

Affiliation of the Leader：

Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer 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：

 SDZLEC2025-071-02

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：

山东第一医科大学附属肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Affiliated Cancer Hospital of Shandong First Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-12 00:00:00

伦理委员会联系人：

宋现让

Contact Name of the ethic committee：

Xianrang Song

伦理委员会联系地址：

山东省济南市槐荫区济兖路440号山东省肿瘤医院

Contact Address of the ethic committee：

Shandong Cancer Hospital, No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 531 6762 6929

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：

山东第一医科大学附属肿瘤医院

Primary sponsor：

Cancer Hospital Affiliated of Shandong First Medical University

研究实施负责（组长）单位地址：

山东省济南市槐荫区济兖路440号

Primary sponsor's address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province, China

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

市(区县)：

济南

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

山东第一医科大学附属肿瘤医院

具体地址：

山东省济南市槐荫区济兖路440号

Institution
hospital：

Cancer Hospital Affiliated of Shandong First Medical University

Address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province, China

经费或物资来源：

阿得贝利单抗（1200 mg，9500元/瓶）全免，由恒瑞医药公司提供

Source(s) of funding：

Adebrelimab (1200 mg) is provided for free and supplied by Hengrui Medicine Co., Ltd.

研究疾病：

非小细胞肺癌  

Target disease：

NSCLC

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

剂量探索阶段：评价阿得贝利单抗联合甲磺酸伏美替尼一线治疗PD-L1高表达、EGFR敏感突变的晚期非小细胞肺癌患者3个月内的肺炎发生率。 剂量拓展阶段：评价阿得贝利单抗联合甲磺酸伏美替尼一线治疗PD-L1高表达、EGFR敏感突变的晚期非小细胞肺癌患者12个月PFS率。  

Objectives of Study：

Dose Exploration Phase: To evaluate the incidence of pneumonia within 3 months in patients with advanced non-small cell lung cancer who have high PD-L1 expression and sensitive EGFR mutations and are receiving first-line treatment with Adebrelimab combined with Furmonertinib Dose Escalation Phase: To evaluate the 12-month Progression-Free Survival (PFS) rate in patients with advanced non-small cell lung cancer who have high PD-L1 expression and sensitive EGFR mutations and are receiving first-line treatment with Adebrelimab combined with Furmonertinib

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. 受试者签署知情同意书时年龄18-75周岁，男女均可。 2. 经组织学或细胞学确诊的不可切除或拒绝手术切除的非小细胞肺癌患者； 3. EGFR驱动基因突变阳性; 4. PD-L1 ≥50%； 5. 既往未接受过针对晚期/转移性非小细胞肺癌的全身系统性治疗，允许系统治疗或放疗作为新辅助/辅助治疗的一部分使用，治疗在诊断出现晚期或转移性疾病前已经结束至少6个月； 6. 根据RECIST 1.1标准，患者必须有通过CT或MRI检查的可测量病灶。肿瘤影像学评价在首次用药前的28天内进行。 7. ECOG评分：0-1分； 8. 预期的生存期≥3个月； 9. 符合研究方案的实验室指标，包括： 1) 血红蛋白（HB）≥90g/L（筛查前 14 天内未输血） 2) 中性粒细胞计数绝对值（ANC）≥1.5×10^9/L； 3) 血小板计数（PLT）≥80×10^9/L； 4) 胆红素<1.25×ULN 5) AST 和 ALT<2.5×ULN 6) 对于有记录到的肝脏转移或骨转移的患者，AST 和 ALT 水平≤5 倍 ULN； 7) 血清肌酐<1.25×ULN，内源性 Cr 清除率> 45 ml / min （Cockcroft-Gault 公式）。 8）凝血功能：活化部分凝血活酶时间（Activated partial thromboplastin time ，APTT）、国际标准化比值（Internationalnormalized ratio ，INR）、凝血酶原时间（Prothrombin time ，PT）≤1.5×ULN； 9）其他： 脂肪酶≤1.5×ULN。若脂肪酶>1.5×ULN 无临床或影像学 证实胰腺炎的情况可以入组; 10）多普勒超声评估：左室射血分数 (LVEF)≥50%； 10. 经本人同意并已签署知情同意书，愿意并有能力遵从计划的访视、研究治疗、实验室检查及其他试验程序； 11. 有生育能力的女性受试者必须在首次用药前 72小时内进行血清妊娠试验，且结果为阴性，且不在哺乳期，并且愿意在研究期间 和末次给予阿得贝利单抗/阿帕替尼后 3个月内或末次给与白蛋白紫杉醇后 6 个月内（以时间长着为准）采用一种经医学认可的高效避孕措施（如：宫内节育器、避孕药或避孕套） ；对于伴侣为有生育能力女性的男性受试者，需手术绝育，或同意在研究期间和末次研究给药后 3 个月内采用有效的方法避孕，研究期间不允许捐精。

Inclusion criteria

1. Subjects should be aged between 18 and 75 years old at the time of signing the informed consent form, regardless of gender. 2. Patients with histologically or cytologically confirmed unresectable or those who decline surgical resection of non - small cell lung cancer. 3. Positive for EGFR - driven gene mutations. 4. PD - L1 >= 50%. 5. Have not previously received systemic treatment for advanced/metastatic non-small cell lung cancer. Systemic treatment or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy, provided that the treatment ended at least 6 months before the diagnosis of advanced or metastatic disease. 6. According to the RECIST 1.1 criteria, patients must have measurable lesions detectable by CT or MRI. Tumor imaging evaluation should be conducted within 28 days before the first dose of the drug. 7. ECOG performance status: 0 - 1. 8. Expected survival time >= 3 months. 9. Meet the laboratory indicators specified in the study protocol, including: 1) Hemoglobin (HB) >= 90 g/L (without blood transfusion within 14 days before screening). 2) Absolute neutrophil count (ANC) >= 1.5×10?/L. 3) Platelet count (PLT) >= 80×10?/L. 4) Bilirubin < 1.25×ULN. 5) AST and ALT < 2.5×ULN. 6) For patients with documented liver or bone metastases, AST and ALT levels <= 5×ULN. 7) Serum creatinine < 1.25×ULN, endogenous Cr clearance rate > 45 ml/min (using the Cockcroft - Gault formula). 8) Coagulation function: Activated partial thromboplastin time (APTT), International normalized ratio (INR), and Prothrombin time (PT) <= 1.5×ULN. 9) Others: Lipase <= 1.5×ULN. Patients with lipase > 1.5×ULN but without clinically or radiologically confirmed pancreatitis can be enrolled. 10) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >= 50%. 10. Have voluntarily signed the informed consent form, and be willing and able to comply with the scheduled visits, study treatments, laboratory tests, and other trial procedures. 11. Female subjects of child - bearing potential must have a negative serum pregnancy test within 72 hours before the first dose of the drug, not be breastfeeding, and be willing to use a medically recognized highly effective contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) during the study period and for 3 months after the last administration of Adebrelimab/Apatinib or 6 months after the last administration of Albumin - bound Paclitaxel (whichever is longer). Male subjects whose partners are of child - bearing potential should have undergone surgical sterilization or agree to use effective contraceptive methods during the study period and for 3 months after the last study drug administration, and are not allowed to donate sperm during the study.

排除标准：

1. 肿瘤组织学或细胞学病理证实合并小细胞肺癌成分，或肉瘤样癌病变； 2. EGFR 突变阴性受试者； 3. PD-L1 ＜50%的受试者； 4. 无可测量病灶的受试者； 5. 有癌性脑膜炎、脊髓压迫等情况的受试者； 6. 未经治疗的中枢神经系统（CNS）肿瘤转移的受试者。如果受试者的CNS肿瘤转移仅限于幕上和/或小脑，已经接受过充分治疗，如临床稳定已维持至少4周，并且受试者的神经系统等临床症状能够在首次用药前至少2周恢复至NCI-CTC AE ≤1度，则可以参与研究。此外，受试者如果使用皮质类固醇激素治疗相关临床症状，接受剂量稳定或逐渐降低的≤10mg/天泼尼松（或等价物）至少2周方可参与研究，否则不能入组。 7. 可以手术切除或根治性放射治疗的受试者； 8. 曾接受过免疫检查点抑制剂或针对EGFR靶点的酪氨酸激酶抑制剂的患者； 9. 已知对PD-L1抗体药物及其组分过敏者。 10. 已知对甲磺酸伏美替尼及其组分过敏者； 11. 目前正在参与和接受其他研究治疗； 12. 既往接受过针对晚期NSCLC的系统治疗，包括系统化疗、靶向治疗、免疫治疗等； 13. 接受研究治疗之前的6个月内，接受了>30Gy的胸部（肺部）放射治疗，但针对骨转移病灶的局部姑息性放疗除外； 14. 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（胸腺肽、干扰素、白介素等），或首次给药前4周内进行过外科大手术或尚未从之前的手术中完全恢复； 15. 患有活动性肺结核（TB）的患者患者，正在接受抗结核治疗或者筛选前1年内接受过抗结核治疗； 16. 症状明显的脑转者； 17. 未控制的胸腔积液、心包积液，或需要反复引流的腹水（一月一次或更频繁），经过引流后症状稳定至少两周可入组； 18. 临床上有未控制的活动性感染，包括但不限于急性肺炎； 19. 既往或现在同时患有其他恶性肿瘤（除了得到根治性治疗且无疾病复发证据的非黑色素瘤的皮肤基底细胞癌或鳞状细胞癌、乳腺/宫颈原位癌、浅表膀胱癌等原位癌）； 20. 患有间质性肺炎、特发性肺纤维化病史、机化性肺炎（如闭塞性细支气管炎）、药物性肺炎、特发性肺炎、胸部CT扫描筛选时发现活动性肺炎证据或其他严重影响肺功能的中重度肺部疾病； 21. 已知具有临床意义的肝脏疾病，包括未治疗的活动性病毒性肝炎、酒精性肝炎或其他肝炎、肝硬化、遗传性肝脏疾病； 22. 已知人类免疫缺陷病毒（HIV）感染（已知HIV抗体阳性）； 23. 有严重的心血管疾病，如纽约心脏病协会（NYHA）2级或以上心力衰竭、不稳定型心绞痛、不稳定型心律失常、入组前6个月内发生的心肌梗死或脑血管意外； 24. 研究开始前2年内，因任何活动性自身免疫性疾病接受过全身免疫抑制药物（即使用皮质类固醇或免疫抑制药物）； 25. 研究开始前4周内接种了活病毒疫苗； 26. 既往接受过同种异体干细胞或实质器官移植的患者； 27. 妊娠或哺乳期女性或者有妊娠可能的女性首次用药前妊娠检测阳性，具有生育能力但不愿意接受避孕措施的患者或其性伴侣不愿意接受避孕措施的； 28. 研究者认为可影响方案依从性（如精神病或药物滥用病史），无法从该临床研究中获益、或影响患者签署知情同意书（如吸毒和药物滥用），或不适宜参加本临床研究的具有临床意义的任何其他疾病或状况（包括但不限于：实验室异常结果、临床上有活动性憩室炎、腹内脓肿、肠梗阻、腹膜转移癌）。

Exclusion criteria：

1. Subjects with histological or cytological pathological confirmation of components of small cell lung cancer or sarcomatoid carcinoma lesions. 2. Subjects with negative EGFR mutations. 3. Subjects with PD-L1 < 50%. 4. Subjects without measurable lesions. 5. Subjects with conditions such as carcinomatous meningitis or spinal cord compression. 6. Subjects with untreated central nervous system (CNS) tumor metastases. Subjects with CNS tumor metastases limited to the supratentorial region and/or cerebellum, who have received adequate treatment, remained clinically stable for at least 4 weeks, and whose neurological and other clinical symptoms have recovered to NCI-CTC AE <= Grade 1 at least 2 weeks before the first administration of the drug can participate in the study. In addition, if subjects are treated with corticosteroids for related clinical symptoms, they can participate in the study only if they have received a stable or gradually decreasing dose of <= 10 mg/day of prednisone (or equivalent) for at least 2 weeks; otherwise, they cannot be enrolled. 7. Subjects who are eligible for surgical resection or radical radiotherapy. 8. Patients who have received immune checkpoint inhibitors or tyrosine kinase inhibitors targeting the EGFR target. 9. Subjects known to be allergic to PD-L1 antibody drugs and their components. 10. Subjects known to be allergic to Furmonertinib Mesylate and its components. 11. Currently participating in and receiving other study treatments. 12. Patients who have previously received systemic treatment for advanced NSCLC, including systemic chemotherapy, targeted therapy, immunotherapy, etc. 13. Received > 30 Gy of thoracic (lung) radiotherapy within 6 months before the study treatment, except for local palliative radiotherapy for bone metastasis lesions. 14. Received traditional Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (such as thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or underwent major surgery within 4 weeks before the first administration and have not fully recovered from the previous surgery. 15. Patients with active tuberculosis (TB), those who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening. 16. Subjects with obvious symptomatic brain metastases. 17. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage (once a month or more frequently). Subjects can be enrolled if their symptoms are stable for at least 2 weeks after drainage. 18. Clinically uncontrolled active infections, including but not limited to acute pneumonia. 19. Previously or currently suffering from other malignancies (except non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, in-situ breast cancer/cervical cancer, superficial bladder cancer, etc. that have been radically treated and have no evidence of disease recurrence). 20. Subjects with a history of interstitial pneumonia, idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, evidence of active pneumonia found during chest CT scan screening, or other moderate to severe lung diseases that seriously affect lung function. 21. Known clinically significant liver diseases, including untreated active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, hereditary liver diseases. 22. Known human immunodeficiency virus (HIV) infection (positive for HIV antibody). 23. Have severe cardiovascular diseases, such as New York Heart Association (NYHA) class 2 or higher heart failure, unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident that occurred within 6 months before enrollment. 24. Received systemic immunosuppressive drugs (i.e., corticosteroids or immunosuppressive drugs) for any active autoimmune disease within 2 years before the start of the study. 25. Received live virus vaccines within 4 weeks before the start of the study. 26. Patients who have previously received allogeneic stem cell or solid organ transplantation. 27. Pregnant or lactating women, women with a positive pregnancy test before the first administration of the drug, patients with childbearing potential who are unwilling to accept contraceptive measures, or whose sexual partners are unwilling to accept contraceptive measures. 28. In the opinion of the investigator, factors that may affect compliance with the protocol (such as a history of mental illness or drug abuse), inability to benefit from this clinical study, or other clinically significant diseases or conditions that affect the patient's ability to sign the informed consent form (such as drug use and drug abuse), including but not limited to abnormal laboratory results, clinically active diverticulitis, intra-abdominal abscess, intestinal obstruction, peritoneal metastatic cancer.

研究实施时间：

Study execute time：

从 From 2025-06-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组（剂量探索阶段）

样本量：

 6

Group：

Test group (Dose exploration stage)

Sample size：

干预措施：

符合条件的6名患者随机分到两组，一组使用甲磺酸伏美替尼80 mg QD和阿得贝利单抗 600mg Q3W，一组使用甲磺酸伏美替尼80 mg QD和阿得贝利单抗 1200mg Q3W，服用60天，直至疾病进展，出现不可耐受毒性或死亡，阿得贝利单抗用药时间不超过2年；

干预措施代码：

Intervention：

Six eligible patients are randomly assigned to two groups. One group receives 80 mg of Furmonertinib Mesilate QD and 600 mg of Adebrelimab Q3W, while the other group receives 80 mg of Furmonertinib Mesylate QD and 1200 mg of Adebrelimab Q3W. The treatment lasts for 60 days until disease progression, intolerable toxicity occurs, or death. The administration of Adebrelimab should not exceed 2 years.

Intervention code：

组别：

实验组（剂量拓展阶段）

样本量：

 30

Group：

Test group (Dose Expansion Stage)

Sample size：

干预措施：

阿得贝利单抗1200mg IV，d1，Q3W；甲磺酸伏美替尼，PO，80mg，QD；直至患者疾病进展或不能耐受，阿得贝利单抗最长用药时间为2年。

干预措施代码：

Intervention：

Adebrelimab 1200 mg IV, Day 1, Q3W; Furmonertinib Mesylate 80 mg PO QD; continue until disease progression or intolerability, with a maximum treatment duration of 2 years for Adebrelimab.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China

Province：

S

City：

单位(医院)：

 山东第一医科大学附属肿瘤医院(山东省肿瘤医院) 

单位级别：

 三级甲等 

Institution
hospital：

Cancer Hospital Affiliated of Shandong First Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

12个月PFS率

指标类型：

主要指标

Outcome：

The 12-month Progression-Free Survival (PFS) 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：

无进展生存期

指标类型：

次要指标

Outcome：

Progress-Free Survive

Type：

Secondary 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：

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：

指标中文名：

疾病控制时间

指标类型：

次要指标

Outcome：

Duration of Response

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：

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：

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:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

无

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

None

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：

病例记录表

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

Case Record Form

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：

  2025-05-16 09:19:05