ChiCTR2600116429 版本V1.0 版本创建时间2026/01/09 15:31:27 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：

ChiCTR2600116429 

最近更新日期：

Date of Last Refreshed on：

2026-01-09 15:31:15 

注册时间：

Date of Registration：

2026-01-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

PD-1单抗联合阿帕替尼联合或不联合化疗维持治疗经PD-1单抗联合化疗诱导未进展的晚期驱动基因阴性NSCLC患者的II期研究

Public title：

A Phase II Study of PD-1 Monoclonal Antibody Combined with Apatinib, With or Without Chemotherapy, as Maintenance Therapy for Patients with Advanced Driver Gene-Negative NSCLC Who Have Not Progressed

注册题目简写：

English Acronym：

研究课题的正式科学名称：

PD-1单抗联合阿帕替尼联合或不联合化疗维持治疗经PD-1单抗联合化疗诱导未进展的晚期驱动基因阴性NSCLC患者的II期研究

Scientific title：

A Phase II Study of PD-1 Monoclonal Antibody Combined with Apatinib, With or Without Chemotherapy, as Maintenance Therapy for Patients with Advanced Driver Gene-Negative NSCLC Who Have Not Progressed After Induction Therapy with PD-1 Monoclonal Antibody Combined with Chemotherapy

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：

费凯伦 

研究负责人：

王志杰 

Applicant：

Kailun Fei 

Study leader：

Zhijie Wang 

申请注册联系人电话：

Applicant telephone：

+86 13717843508

研究负责人电话：

Study leader's telephone：

+86 10 87788029

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：

fkl6311@163.com

研究负责人电子邮件：

Study leader's E-mail：

jie_969@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：

中国北京市朝阳区潘家园南里17号

研究负责人通讯地址：

中国北京市朝阳区潘家园南里17号

Applicant address：

No. 17, Nanli, Panjiaohai, Chaoyang District, Beijing, China

Study leader's address：

No. 17, Nanli, Panjiaohai, Chaoyang District, Beijing, China

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：

中国医学科学院肿瘤医院

Applicant's institution：

Cancer Hospital Chinese Academy of Medical Sciences

研究负责人所在单位：

中国医学科学院肿瘤医院

Affiliation of the Leader：

Cancer Hospital Chinese Academy of Medical Sciences

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：

25/066-5012

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：

中国医学科学院肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of Chinese Academy of Medical Sciences and Peking Union Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

2025-04-28 00:00:00

伦理委员会联系人：

吴大维

Contact Name of the ethic committee：

Dawei Wu

伦理委员会联系地址：

北京市朝阳区潘家园南里17号

Contact Address of the ethic committee：

No. 17, Nanli, Panjiaohai, Chaoyang District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 87788495

伦理委员会联系人邮箱：

Contact email of the ethic committee：

wumingshi-117@163.com

研究实施负责（组长）单位：

中国医学科学院肿瘤医院

Primary sponsor：

Cancer Hospital Chinese Academy of Medical Sciences

研究实施负责（组长）单位地址：

中国北京市朝阳区潘家园南里17号

Primary sponsor's address：

No. 17, Nanli, Panjiaohai, Chaoyang District, Beijing, 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)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国医学科学院肿瘤医院

具体地址：

中国北京市朝阳区潘家园南里17号

Institution
hospital：

Cancer Hospital Chinese Academy of Medical Sciences

Address：

No. 17, Nanli, Panjiaohai, Chaoyang District, Beijing, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected topic (self-funded)

Target disease：

Patients with pathologically or histologically confirmed advanced driver gene-negative NSCLC who have received first-line PD-1 monoclonal antibody combined with chemotherapy and have not progressed.

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

探索PD-1单抗联合阿帕替尼联合或不联合化疗维持治疗经PD-1单抗联合化疗诱导未进展的晚期驱动基因阴性NSCLC患者的有效性和安全性  

Objectives of Study：

Exploring the efficacy and safety of PD-1 monoclonal antibody combined with apatinib, with or without chemotherapy, as maintenance therapy for patients with advanced driver gene-negative NSCLC who have not progressed after induction therapy with PD-1 monoclonal antibody combined with chemotherapy

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 18－70 周岁，男女不限； 2. 病理组织学或细胞学证实的不能手术切除且不能接受根治性放化疗的局部晚期（ⅢB/ⅢC 期）及 IV 期非小细胞肺癌（根据AICC第八版）； 3. 从最初诊断开始后的任何时候，EGFR 突变和 ALK 易位状况确认为阴性； 4. 受试者既往接受一线PD-1单抗联合化疗诱导治疗后未疾病进展，评效为CR/PR/SD，且不良反应耐受； 5. ECOG评分；0-1分； 6. 按照 RECIST v1.1 标准，受试者必须有通过 CT 或 MRI 检查的可测量靶病灶。 7. 主要器官功能正常，筛选时的试验结果必须符合以下要求： 1) 血常规检查标准需符合(14天内未输血及血制品，未使用G-CSF及其他造血刺激因子纠正)： A. 血红蛋白(Hb) ≥ 90 g/L； B. 中性粒细胞数(ANC) ≥ 1.5 × 10^9/L； C. 血小板计数(PLT) ≥ 100 ×10^9/L； 2) 生化检查需符合以下标准： A. 总胆红素(TBIL) < 1.5 正常值上限(ULN)； B. 谷丙转氨酶(ALT)和谷草转氨酶(AST) < 2.5 ULN，而对于肝转移患者则< 5 ULN； C. 血清肌酐(Cr) <= 1.5 ULN或者内生肌酐清除率> 60ml/min（Cockcroft-Gault公式）； D. 尿常规检测结果显示尿蛋白(UPRO) < 2+ 或24小时尿蛋白定量<1g； 8. 孕龄期男性及女性必须同意在整个研究期间及治疗结束后6个月内采取充分避孕措施。 9. 签署书面知情同意书，预计对研究方案依从性良好。

Inclusion criteria

1.The age of participants ranged from 18 to 70 years old when they signed the informed consent form. 2.Pathologically confirmed, unresectable, and ineligible for curative radiotherapy or chemotherapy, locally advanced (Stage III B/III C) or Stage IV non-small cell lung cancer (according to the 8th edition of the AICC); 3.At any time after initial diagnosis, EGFR mutations and ALK rearrangements were confirmed to be negative; 4.Participants had previously received first-line PD-1 monoclonal antibody combined with chemotherapy induction therapy without disease progression, with response evaluation of CR/PR/SD, and tolerated adverse reactions; 5.ECOG performance status: 0–1 points; 6.According to RECIST v1.1 criteria, the subject must have measurable target lesions confirmed by CT or MRI imaging. 7.Normal major organ function, with screening test results meeting the following requirements: 1) Blood routine examination standards must meet the following requirements (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulants for correction): A. Hemoglobin (Hb) ≥ 90 g/L; B. Neutrophil count (ANC) >=1.5 × 10^9/L; C. Platelet count (PLT) >=100 × 10^9/L; 2) Biochemical tests must meet the following standards: A. Total bilirubin (TBIL) < 1.5 times the upper limit of normal (ULN); B. Alanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 ULN, and < 5 ULN for patients with liver metastases; C. Serum creatinine (Cr) <= 1.5 ULN or estimated glomerular filtration rate (eGFR) > 60 ml/min (Cockcroft-Gault formula); D. Urinalysis results show urine protein (UPRO) < 2+ or 24-hour urine protein quantification < 1 g; 8.Male and female participants of reproductive age must agree to use adequate contraceptive measures throughout the study period and for 6 months after treatment. 9.Sign a written informed consent form, with good compliance expected with the study protocol.

排除标准：

1. 组织学或细胞学确认的混合型NSCLC，包括鳞腺混合癌受试者、含小细胞肺癌成份的 NSCLC 受试者；
2. 既往接受抗 PD-L1 抗体、抗 PD-L2 抗体、抗CTLA-4 抗体（或作用于 T 细胞协同刺激或检查点通路的任何其他抗体）或任何VEGF/VEGFR抑制剂；
3. 活动性脑转移患者（对于脑转移病灶经治疗后症状稳定的患者，保持稳定状态至少4周可入选）；
4. 有肿瘤空洞、肿瘤包绕或侵犯大血管的影像学证据。此外，应考虑肿瘤接近大血管的程度。（胸部的大血管包括主动脉、左肺动脉 、右肺动脉、 4个肺静脉、上腔静脉、下腔静脉和主动脉）。
5. 首次使用PD-1单抗前28天之内使用过免疫抑制药物，不包括喷鼻和吸入性皮质类固醇或生理剂量的系统性类固醇激素（即不超过10 mg/天强的松龙或同等药物生理学剂量的其他皮质类固醇）；
6. 首次给药前28周内接受过具有抗肿瘤适应症的中草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）的系统性全身治疗；
7. 首次用药30天内或预期在研究期间内接种减毒活疫苗；（对于新冠疫苗接种者根据研究者判断可否入选）；
8. 根据研究者判断存在不可控制的胸腔积液、心包积液或腹水，或在接受治疗前4周内接受过以治疗为目的的浆膜腔积液引流者。
9. 入组前1月内发生过严重感染的受试者，包括但不限于需要住院治疗的感染并发症、菌血症、重症肺炎等；伴有任何活动性感染的受试者，或在筛选期间、首次给药前发生原因不明发热>38.5℃；
10. 存在活动性自身免疫病或免疫缺陷，或具有上述病史，自包括但不局限于：自身免疫性肝炎、间质性肺炎，葡萄膜炎、类风湿性关节炎、炎症性肠病、垂体炎、血管炎、肾炎等）不得纳入。以下情况例外：自身免疫性甲状腺机能减退病史但接受甲状腺激素替代疗法的患者可入选研究。 通过胰岛素给药方案治疗后，血糖得以控制的 1 型糖尿病患者可参与本项研究。
11. 受试者进行支气管扩张剂等系统治疗，哮喘控制不满意，不能纳入（在童年期哮喘已完全缓解，成人后无需任何干预的可纳入）。
12. 人类免疫缺陷病毒（HIV）感染或已知有获得性免疫缺陷综合征（艾滋病），未经治疗的活动性乙型肝炎，丙型肝炎（丙肝抗体阳性，且 HCV-RNA 高于分析方法的检测下限）或合并乙肝和丙肝共同感染； 注：符合下列标准的乙肝受试者也符合入选条件：首次给药前 HBV 病毒载量必须<1000 拷贝/ml（200 IU/ml），受试者应在整个研究化疗药物治疗期间接受抗HBV 治疗避免病毒再激活。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；
1.应在整个研究化疗药物治疗期间接受抗HBV 治疗避免病毒再激活。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； 13. 受试者已经或计划在研究期间接受实体脏器或血液系统移植（角膜移植除外）；
14. 五年内有其他恶性肿瘤病史的受试者（原位宫颈癌或基底细胞癌或鳞状细胞癌皮肤癌的完全治疗除外）；
15. 患有高血压，且经降压药物治疗无法获得良好控制（收缩压≥140 mmHg或者舒张压≥90 mmHg）；
16. 有未能良好控制的心脏临床症状或疾病，如：（1）NYHA2级以上心力衰竭（2）不稳定型心绞痛（3）1年内发生过心肌梗死（4）有临床意义的室上性或室性心律失常需要治疗或干预 （5）QTc>450ms（男性）；QTc>470ms (女性)；
17. 凝血功能异常（INR>2.0、PT>16s），具有出血倾向或正在接受溶栓或抗凝治疗，允许预防性使用小剂量阿司匹林、低分子肝素；
18. 入组前2个月内出现临床显著的咯鲜血或每日咯血大于半茶匙（2.5ml）或以上；或显著临床意义的出血症状或具有明确的出血倾向，如消化道出血、出血性胃溃疡、基线期大便潜血++及以上，或患有脉管炎等；存在深大溃疡，与大血管、上下颌骨关系密切的病灶；
19. 入组前 6 个月内发生的动/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、脑梗塞）、深静脉血栓及肺栓塞等；已知存在的遗传性或获得性出血及血栓倾向（如血友病人，凝血机能障碍，血小板减少等）；
20. 尿常规提示尿蛋白≥ ++并经证实24小时尿蛋白量>1.0 g；
21. 当前正在参与干预性临床研究治疗，或在首次给药前4周内接受过其他试验药物或研究器械治疗；在首次给药前，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）；
22. 有明确过敏史，可能对试验药物及其类似生物制剂潜在过敏或不耐受；
23. 具有精神类药物滥用史且无法戒除者或有精神障碍的；
24. 增加参加研究或试验药物相关的风险，并且根据研究者的判断，可导致患者不适合入选研究的其他情况。

Exclusion criteria：

1.Histologically or cytologically confirmed mixed-type NSCLC, including patients with squamous-adenocarcinoma mixed cancer and patients with NSCLC containing small cell lung cancer components; 2.Previous treatment with anti-PD-L1 antibodies, anti-PD-L2 antibodies, anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or checkpoint pathways), or any VEGF/VEGFR inhibitors; 3.Patients with active brain metastases (patients with stable symptoms following treatment for brain metastases may be eligible if the stable condition has been maintained for at least 4 weeks); 4.Imaging evidence of tumor cavities, tumor encasement, or invasion of major vessels. Additionally, the proximity of the tumor to major vessels should be considered. (Major vessels in the chest include the aorta, left pulmonary artery, right pulmonary artery, four pulmonary veins, superior vena cava, inferior vena cava, and aorta.); 5.Use of immunosuppressive drugs within 28 days prior to the first administration of PD-1 monoclonal antibodies, excluding nasal or inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e., no more than 10 mg/day of prednisolone or equivalent physiological doses of other corticosteroids); 6.Systemic treatment with herbal medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) with antitumor indications within 28 weeks prior to the first dose; 7.Received a live attenuated vaccine within 30 days prior to the first dose or is expected to receive one during the study period; (For COVID-19 vaccine recipients, eligibility may be determined at the investigator's discretion); 8.Uncontrolled pleural effusion, pericardial effusion, or ascites, as determined by the investigator, or having undergone serous cavity drainage for therapeutic purposes within 4 weeks prior to treatment. 9.Subjects who have experienced severe infections within 1 month prior to enrollment, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; subjects with any active infections, or those who experienced unexplained fever >38.5°C during screening or prior to the first dose; 10.Participants with active autoimmune diseases or immunodeficiencies, or with a history of such conditions, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitary inflammation, vasculitis, nephritis, etc., are excluded. Exceptions: Participants with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be eligible for the study. Patients with type 1 diabetes whose blood glucose is controlled through insulin administration may participate in this study. 11.Participants receiving systemic treatment with bronchodilators or other agents for asthma that is not adequately controlled are ineligible (those who achieved complete remission of asthma during childhood and require no intervention in adulthood may be included). 12.Participants with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (HCV antibody positive and HCV-RNA above the detection limit of the analytical method), or co-infection with hepatitis B and C; Note: HBV-infected subjects meeting the following criteria are also eligible for inclusion: HBV viral load must be <1000 copies/ml (200 IU/ml) prior to the first dose, and subjects must receive antiviral therapy to prevent viral reactivation throughout the study chemotherapy treatment period. For subjects who are anti-HBc positive, HBsAg negative, anti-HBs negative, and HBV viral load negative, prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary; 13.Subjects who have undergone or plan to undergo solid organ or hematopoietic stem cell transplantation (excluding corneal transplantation) during the study period; 14.Subjects with a history of other malignant tumors within the past five years (excluding complete treatment for in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma of the skin); 15.Subjects with hypertension that cannot be adequately controlled with antihypertensive medications (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 16.Uncontrolled cardiac symptoms or diseases, such as: (1) NYHA Class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc > 450 ms (male); QTc > 470 ms (female); 17.Abnormal coagulation function (INR > 2.0, PT > 16 seconds), with a tendency to bleed or currently receiving thrombolytic or anticoagulant therapy; prophylactic use of low-dose aspirin or low-molecular-weight heparin is permitted; 18.Clinical significant hemoptysis within 2 months prior to enrollment, or daily hemoptysis exceeding half a teaspoon (2.5 ml) or more; or significant clinical bleeding symptoms or a clear tendency to bleed, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood test result of ++ or higher, or vasculitis; Presence of deep, large ulcers closely associated with major vessels or the maxilla and mandible; 19.Occurrence of arterial or venous thromboembolic events within 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism; known hereditary or acquired bleeding or thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.); 20.Urinalysis indicating urine protein >= ++ and confirmed 24-hour urine protein excretion > 1.0 g; 21.Currently participating in an interventional clinical trial or having received treatment with other investigational drugs or devices within 4 weeks prior to the first dose; not yet fully recovered from toxicity and/or complications caused by any intervention (i.e., <= Grade 1 or returned to baseline, excluding fatigue or hair loss) prior to the first dose; 22.Has a history of allergies that may result in potential hypersensitivity or intolerance to the investigational drug or its biologically similar products; 23.Has a history of substance abuse with psychotropic drugs and is unable to abstain, or has a psychiatric disorder; 24.Presents increased risks associated with participation in the study or the investigational drug, and other conditions, as determined by the investigator, that may render the patient ineligible for inclusion in the study.

研究实施时间：

Study execute time：

从 From 2025-04-25 00:00:00至 To 2029-04-24 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-23 00:00:00 至 To 2028-01-22 00:00:00  

干预措施：

Interventions：

组别：

非鳞癌NSCLC组

样本量：

44

Group：

Non-lung squamous cell carcinoma group

Sample size：

干预措施：

PD-1抑制剂联合阿帕替尼和化疗

干预措施代码：

Intervention：

PD-1 inhibitor combined with apatinib and chemotherapy

Intervention code：

组别：

鳞癌NSCLC组

样本量：

42

Group：

Lung squamous cell carcinoma group

Sample size：

干预措施：

PD-1抑制剂联合阿帕替尼

干预措施代码：

Intervention：

PD-1 inhibitor combined with apatinib

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

中国医学科学院肿瘤医院 

单位级别：

三级甲等 

Institution
hospital：

Cancer Hospital Chinese Academy of Medical Sciences

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：

从接受治疗开始，至第一次记录肿瘤进展（按照 RECIST 1.1 标准评定，无论是否继续治疗）的日期或因任何原因死亡的日期，以先出现的为准

测量方法：

按照 RECIST 1.1 标准评定

Measure time point of outcome：

From the start of treatment until the date of the first recorded tumor progression (assessed accordi

Measure method：

Assessed according to RECIST 1.1 criteria

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：

从首次治疗开始，每两个治疗周期评估一次，直至治疗结束

测量方法：

按照 RECIST 1.1 标准评定

Measure time point of outcome：

Starting from the first treatment, evaluations are conducted every two treatment cycles

Measure method：

Assessed according to RECIST 1.1 criteria

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：

从接受治疗开始到因各种原因导致受试者死亡之间的时间

测量方法：

定期随访

Measure time point of outcome：

The time from the start of treatment to the death of the subject for various reasons.

Measure method：

Regular follow-up visits

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 70 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）：

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, CRF CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-09 15:31:15