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：	ChiCTR2600125883
最近更新日期： Date of Last Refreshed on：	2026-06-01 15:27:48
注册时间： Date of Registration：	2026-06-01 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	阿帕替尼治疗卡瑞利珠单抗治疗晚期非小细胞肺癌诱发的RCCEP的真实世界研究
Public title：	Real-world study of apatinib in the treatment of RCCEP induced by camrelizumab in patients with advanced non-small cell lung cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	阿帕替尼治疗卡瑞利珠单抗治疗晚期非小细胞肺癌诱发的RCCEP的真实世界研究
Scientific title：	Real-world study of apatinib in the treatment of RCCEP induced by camrelizumab in patients with advanced non-small cell lung cancer
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：	马爱平	研究负责人：	马爱平
Applicant：	Ma Aiping	Study leader：	Ma Aiping
申请注册联系人电话： Applicant telephone：	+86 159 6026 5053	研究负责人电话： Study leader's telephone：	+86 592 213 7264
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：	470718338@qq.com	研究负责人电子邮件： Study leader's E-mail：	maaiping07@sina.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：	中国福建省厦门市思明区镇海路55号	研究负责人通讯地址：	中国福建省厦门市思明区镇海路55号
Applicant address：	No. 55, Zhenhai Road, Siming District, Xiamen, Fujian, China	Study leader's address：	No. 55, Zhenhai Road, Siming District, Xiamen, Fujian, 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：	厦门大学附属第一医院
Applicant's institution：	The First Affiliated Hospital of Xiamen University
研究负责人所在单位：	厦门大学附属第一医院
Affiliation of the Leader：	The First Affiliated Hospital of Xiamen University

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：	[2026]科研伦审字（079）号	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：	厦门大学附属第一医院临床研究伦理委员会
Name of the ethic committee：	Clinical Research Ethics Committee of the First Affiliated Hospital of Xiamen University
伦理委员会批准日期： Date of approved by ethic committee：	2026-04-20 00:00:00
伦理委员会联系人：	曹伟
Contact Name of the ethic committee：	Cao Wei
伦理委员会联系地址：	中国福建省厦门市思明区镇海路55号
Contact Address of the ethic committee：	No. 55, Zhenhai Road, Siming District, Xiamen, Fujian, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 592 213 7569	伦理委员会联系人邮箱： Contact email of the ethic committee：	xdfyec@sina.com

研究实施负责（组长）单位：

厦门大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Xiamen University

研究实施负责（组长）单位地址：

中国福建省厦门市思明区镇海路55号

Primary sponsor's address：

No. 55, Zhenhai Road, Siming District, Xiamen, Fujian, 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)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	厦门大学附属第一医院	具体地址：	中国福建省厦门市思明区镇海路55号
Institution hospital：	The First Affiliated Hospital of Xiamen University	Address：	No. 55, Zhenhai Road, Siming District, Xiamen, Fujian, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funding

研究疾病：

接受以卡瑞利珠单抗为基础的治疗时出现≥1级RCCEP

Target disease：

Grade >=1 RCCEP during treatment with camrelizumab-based therapy

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

队列研究

Study design：

Cohort study

研究目的：

探索阿帕替尼治疗卡瑞利珠单抗治疗晚期非小细胞肺癌诱发的RCCEP的至RCCEP中位消失时间、4周RCCEP治愈率、8 周 RCCEP治愈率、恢复到1级以下RCCEP的发生率（≥2级）、RCCEP级别减轻率、4周RCCEP级别减轻率、8周RCCEP级别减轻率。安全性：探索阿帕替尼治疗卡瑞利珠单抗治疗晚期非小细胞肺癌诱发的RCCEP的不良事件（AE）发生率、实验室检查异常值和严重不良事件（SAE）的发生率。

Objectives of Study：

Explore the median time to resolution of RCCEP, 4-week RCCEP cure rate, 8-week RCCEP cure rate, incidence of RCCEP regression to below grade 1 ( >= grade 2), RCCEP grade reduction rate, 4-week RCCEP grade reduction rate, and 8-week RCCEP grade reduction rate in patients with RCCEP induced by advanced non-small cell lung cancer treated with apatinib and camrelizumab. Safety: Explore the incidence of adverse events (AEs), laboratory abnormalities, and serious adverse events (SAEs) in patients with RCCEP induced by advanced non-small cell lung cancer treated with apatinib and camrelizumab.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1.Age range: 18 - 75 years old (inclusive of 18 and 75), gender not restricted.
2. Stage IV non-small cell lung cancer confirmed by pathological histology or cytology (according to the eighth edition of the International Union Against Cancer/American Joint Committee on Cancer Cancer Staging System).
3. There is at least one measurable lesion, in accordance with the RECIST 1.1 standard.
4. When receiving treatment based on carilizumab, the first occurrence of >= 1 grade 1 RCCEP was observed.
5. Physical condition score (ECOG PS score): 0 - 1 point.
6. Expected survival period >= 3 months.
7. Negative for EGFR or ALK mutations.
8. No active brain metastasis.
9. The major organs function well, that is, within the 14 days prior to enrollment, the relevant test indicators met the following requirements: hemoglobin >= 90 g/L (no blood transfusion within 14 days); neutrophil count > 1.5×10^9/L; platelet count >= 100×10^9/L; total bilirubin <= 1.5×ULN (upper limit of normal value); blood alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <= 2.5×ULN; if there is liver metastasis, ALT or AST <= 5×ULN; endogenous creatinine clearance rate >= 60 mL/min (Cockcroft-Gault formula); cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%.
10. Women of childbearing age must undergo a serum pregnancy test 7 days prior to the first administration of the drug, and the result must be negative. Male subjects who are the partners of women of childbearing age and are also women of childbearing age must agree to use an effective method of contraception during the study and for 180 days after the last administration of the study drug.
11. Understand the research procedures and contents, and voluntarily sign a written informed consent form.

排除标准：

1.诊断为其他病理组织学类型的非小细胞肺癌受试者，包括鳞腺混合癌受试者、含小细胞肺癌成份的NSCLC受试者。
2.已知EGFR突变或ALK阳性受试者。
3.既往接受过除卡瑞利珠单抗外的PD-(L)1、CTLA-4治疗的受试者。
4.不允许使用过抗血管生成药物。
5.不允许使用除阿帕替尼以外的针对 RCCEP 的治疗。
6.有遗传性出血倾向或凝血功能障碍。入组前3个月内出现过有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。病灶有明显的血管侵犯。
7.存在活动性中枢神经系统（CNS）转移的受试者。如果受试者的CNS转移能够充分治疗，如临床稳定（MRI检测）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周恢复到基线水平（与CNS治疗有关的残留体征或症状除外），则可以参加研究。此外，受试者如果使用皮质类固醇类激素治疗相关临床症状，接受剂量稳定或逐渐降低的≤10 mg/天的泼尼松（或等价物）至少2周方可参加研究，否则不能入组。
8.患有活跃的、已知的或怀疑患有自身免疫性疾病的受试者。接受稳定剂量胰岛素治疗的I型糖尿病受试者、只需要激素替代治疗的甲状腺功能减退受试者、以及不需要系统治疗且在筛查期前一年内没有急性恶化的皮肤病(如湿疹、白癜风或牛皮鲜)可以纳入。
9.患有先天或后天免疫功能缺陷，如人类免疫缺陷病毒（HIV）感染者。
10.患有以下控制不佳的传染病：活动性乙型病毒性肝炎（HBsAg阳性且HBV DNA≥2000IU/ml或12500copies/ml）或丙型病毒性肝炎（丙肝抗体阳性且HCV-RNA 高于分析方法的检测下限）；活动性结核或目前正在接受抗结核治疗；
11.既往或现在有特发性肺纤维化、间质性肺炎、尘肺、放射性肺炎、组织性肺炎(如支气管炎、闭塞性血管炎)、药物性肺炎、CT检查中的活动性肺炎或肺功能严重受损的客观证据； 12.心脏功能和疾病符合下述情况之一，研究者认为具有临床意义，明显异常而不适合入组本研究的心律失常，包括但不限于完全性左束支传导异常，II度房室传导阻滞；
12. 心脏功能和疾病符合下述情况之一，研究者认为具有临床意义，明显异常而不适合入组本研究的心律失常，包括但不限于完全性左束支传导异常，II 度房室传导阻滞；12 导联心电图（ECG）测量，QTc 间期男性≥450ms、女性 ≥470ms ；美国纽约心脏学会（NYHA）分级≥3 级心功能不全或心脏彩超检查：左室射血分数(LVEF)＜50% ；筛选前 1 年内发生过心肌梗死。
13.入组前4周内发生过严重感染（CTCAE＞2级），如需治疗的感染并发症、菌血症、重症肺炎等；首次使用药物前2周内存在感染的症状和体征需要口服或静脉使用抗生素治疗（不包括预防性使用抗生素的情况）由于感染引起的需要全身性使用抗生素的受试者。
14.诊断为免疫缺陷或研究入组前7天内正在接受与肿瘤治疗非直接相关的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）。
15.入组前≤5年并发其他恶性肿瘤，可以充分治疗的宫颈原位癌、基底细胞或鳞状上皮细胞皮肤癌、根治术后的局部前列腺癌、根治术后的导管原位癌除外。
16.入组前 4 周内或计划在本研究期间接受大手术（不包括诊断性的外科手术）。
17.入组前 4 周内接种过或计划在研究期间接种活疫苗。
18.酒精依赖者或近 1年内有吸毒或药物滥用史。
19.已知有明确的神经或精神障碍，如癫痫、痴呆症，或存在外周神经系统障碍者。
20.已知有异体器官移植史或异体造血干细胞移植史。
21.怀孕或者哺乳期妇女；有生育能力的受试者不愿或无法采取有效的避孕措施者。
22.已知对研究药物或辅料过敏。
23.入组前 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；根据研究者的判断，患有可能混淆研究结果、干扰受试者参与研究程序或不符合受试者参加研究最佳利益的任何疾病、治疗或实验室异常的受试者。
24.根据研究者的判断，患有可能混淆研究结果、干扰受试者参与研究程序或不符合受试者参加研究最佳利益的任何疾病、治疗或实验室异常的受试者。

Exclusion criteria：

1.The subjects diagnosed with other pathological types of non-small cell lung cancer, including those with squamous adenocarcinoma and those with NSCLC containing small cell lung cancer components. 2. Subjects with known EGFR mutations or ALK positive conditions. 3. Subjects who have previously received PD-(L)1 or CTLA-4 therapy other than carfilzomib. 4. The use of anti-angiogenic drugs that have been previously used is not permitted. 5. Treatment other than apatinib for RCCEP is not allowed. 6. Have a hereditary bleeding tendency or coagulation dysfunction. Within 3 months before enrollment, have had clinically significant bleeding symptoms or have a clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcers, baseline fecal occult blood ++ or above. The lesion has obvious vascular invasion. 7. Subjects with active central nervous system (CNS) metastases. If the CNS metastases of the subjects can be adequately treated, such as when the clinical stability (detected by MRI) has been maintained for at least 4 weeks, and the neurological symptoms of the subjects can recover to the baseline level (excluding residual signs or symptoms related to CNS treatment) at least 2 weeks before the first administration of the drug, they can participate in the study. Additionally, if the subjects use corticosteroid hormones to treat related clinical symptoms and receive a stable or gradually reduced dose of ≤ 10 mg/day of prednisone (or equivalent) for at least 2 weeks, they can participate in the study; otherwise, they cannot be enrolled. 8. Subjects with active, known or suspected autoimmune diseases. Subjects with stable dose insulin treatment for type 1 diabetes, subjects with hypothyroidism requiring hormone replacement therapy, and subjects without systemic treatment and without acute deterioration of skin diseases (such as eczema, vitiligo or psoriasis) within one year before screening can be included. 9. Those with congenital or acquired immune deficiencies, such as individuals infected with the Human Immunodeficiency Virus (HIV). 10. Have the following poorly controlled infectious diseases: active hepatitis B (with positive HBsAg and HBV DNA >= 2000 IU/ml or 12500 copies/ml) or hepatitis C (with positive hepatitis C antibody and HCV-RNA above the detection limit of the analytical method); active tuberculosis or currently undergoing anti-tuberculosis treatment. 11. There is a previous or current objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pneumonia, organizing pneumonia (such as bronchitis, obliterative arteritis), drug-induced pneumonia, active pneumonia detected by CT, or severe impairment of lung function; 12. The cardiac function and diseases meet one of the following conditions, which the researchers consider to have clinical significance and are significantly abnormal and unsuitable for inclusion in this study. Arrhythmias include but are not limited to complete left bundle branch block, second-degree atrioventricular block; 12-lead electrocardiogram (ECG) measurement, QTc interval for males>= 450ms, females >= 470ms; New York Heart Association (NYHA) classification >= 3 grade heart dysfunction or echocardiography examination: left ventricular ejection fraction (LVEF) < 50%; within the past 1 year, myocardial infarction occurred. 13. Within 4 weeks prior to enrollment, the subject had experienced a severe infection (CTCAE > grade 2), such as infectious complications requiring treatment, bacteremia, severe pneumonia, etc.; within 2 weeks before the first use of the drug, the subject had symptoms and signs of infection that required oral or intravenous antibiotic treatment (excluding cases of prophylactic use of antibiotics); subjects who required systemic use of antibiotics due to infection. 14. Diagnosed with immunodeficiency or having received systemic glucocorticoid therapy (not directly related to tumor treatment) or any other form of immunosuppressive therapy within 7 days prior to enrollment in the study; Use of physiological doses of glucocorticoids (<=10 mg/day of prednisone or equivalent drugs) is permitted. 15. Participants who had concurrent other malignant tumors within the previous 5 years (except for cervical carcinoma in situ that can be fully treated, basal cell or squamous epithelial cell skin cancer after radical surgery, and ductal carcinoma in situ after radical prostatectomy) are excluded. 16. Within the previous 4 weeks prior to enrollment or planned to undergo major surgery during the course of this study (excluding diagnostic surgical procedures). 17. Within the previous 4 weeks prior to enrollment, the participant had received or was scheduled to receive an live vaccine during the study period. 18. Individuals with alcohol dependence or a history of drug use or substance abuse within the past 1 year. 19. Those who have known definite neurological or mental disorders, such as epilepsy, dementia, or have peripheral nervous system disorders. 20. It is known that there is a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 21. Pregnant or lactating women; subjects with reproductive capacity who are unwilling or unable to take effective contraceptive measures. 22. Known to be allergic to the studied drug or excipient. 23. Within 4 weeks prior to enrollment, the subject had received any other investigational drug treatment or participated in another interventional clinical study; according to the investigator's judgment, the subject had any disease, treatment, or laboratory abnormality that might confound the research results, interfere with the subject's participation in the research procedure, or be inconsistent with the best interests of the subject in participating in the study. 24. According to the researchers' judgment, subjects who have any diseases, treatments, or laboratory abnormalities that may confuse the research results, interfere with the participants' participation in the research procedures, or are not in the best interests of the participants' participation in the research.

研究实施时间：

Study execute time：

从 From 2026-01-15 00:00:00至 To 2029-01-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2028-12-01 00:00:00

干预措施：

Interventions：

组别：	观察组	样本量：	100
Group：	Observation group	Sample size：	100
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	厦门大学附属第一医院	单位级别：	三级甲等
Institution hospital：	The First Affiliated Hospital of Xiamen University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	RCCEP 级别减轻率	指标类型：	次要指标
Outcome：	RCCEP level reduction rate	Type：	Secondary indicator
测量时间点：	阿帕替尼开始用药至末次用药30天内	测量方法：	RCCEP 级别下降的受试者所占的比例
Measure time point of outcome：	From the start of apatinib administration to within 30 days of the last dose	Measure method：	The proportion of subjects with a decrease in the RCCEP level

指标中文名：	3 周 RCCEP 治愈率	指标类型：	次要指标
Outcome：	3-week RCCEP cure rate	Type：	Secondary indicator
测量时间点：	首次治疗开始到 3 周后	测量方法：	首次治疗开始到 3 周后 RCCEP 恢复至 0 级的受试者所占的比例
Measure time point of outcome：	From the beginning of the first treatment to 3 weeks later	Measure method：	The proportion of subjects whose RCCEP returned to grade 0 from the start of the first treatment to 3 weeks later

指标中文名：	RCCEP 治愈率	指标类型：	主要指标
Outcome：	RCCEP cure rate	Type：	Primary indicator
测量时间点：	阿帕替尼开始用药至末次用药30天内	测量方法：	RCCEP 恢复至 0 级的受试者所占的比例（根据《2023CSCO 免疫检查点抑制剂毒性管理指南》）
Measure time point of outcome：	From the start of apatinib administration to within 30 days of the last dose	Measure method：	The proportion of subjects whose RCCEP has returned to level 0 (according to the "2023 CSCO Guidelines for Managing Toxicity of Immune Checkpoint Inhibitors")

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：	阿帕替尼开始用药至末次用药30天内	测量方法：	依据 NCI-CTCAE6.0 标准判断不良事件（AE）、严重不良事件（SAE）的发生率及严重程度
Measure time point of outcome：	From the start of apatinib administration to within 30 days of the last dose	Measure method：	Based on the NCI-CTCAE 6.0 standard, the incidence and severity of adverse events (AE) and serious adverse events (SAE) were determined.

指标中文名：	3 周 RCCEP 级别减轻率	指标类型：	次要指标
Outcome：	3-week RCCEP level reduction rate	Type：	Secondary indicator
测量时间点：	首次治疗开始到 3 周后	测量方法：	首次治疗开始到 3 周后 RCCEP 级别下降的受试者所占的比例
Measure time point of outcome：	From the beginning of the first treatment to 3 weeks later	Measure method：	The proportion of subjects whose RCCEP levels decreased from the start of the first treatment to 3 weeks later

指标中文名：	6 周 RCCEP 治愈率	指标类型：	次要指标
Outcome：	6-week RCCEP cure rate	Type：	Secondary indicator
测量时间点：	首次治疗开始到 6 周后	测量方法：	首次治疗开始到 6 周后 RCCEP 恢复至 0 级的受试者所占的比例
Measure time point of outcome：	From the beginning of the first treatment to 6 weeks later	Measure method：	The proportion of subjects whose RCCEP returned to grade 0 from the start of the first treatment to 6 weeks later

指标中文名：	6 周 RCCEP 级别减轻率	指标类型：	次要指标
Outcome：	6-week RCCEP level reduction rate	Type：	Secondary indicator
测量时间点：	首次治疗开始到 6周后	测量方法：	首次治疗开始到 6 周后 RCCEP 级别下降的受试者所占的比例。
Measure time point of outcome：	From the beginning of the first treatment to 6 weeks later	Measure method：	The proportion of subjects whose RCCEP levels decreased from the start of the first treatment to 6 weeks later

指标中文名：	至RCCEP中位消失时间	指标类型：	次要指标
Outcome：	To the median disappearance time of RCCEP	Type：	Secondary indicator
测量时间点：	阿帕替尼开始用药至末次用药30天内	测量方法：	首次治疗开始到 RCCEP 恢复至 0 级的中位时间（根据《2023CSCO 免疫检查点抑制剂毒性管理指南》）
Measure time point of outcome：	From the start of apatinib administration to within 30 days of the last dose	Measure method：	The median time from the start of the first treatment to the recovery of RCCEP to grade 0(according to the "2023 CSCO Guidelines for Managing Toxicity of Immune Checkpoint Inhibitors")

指标中文名：	恢复到 1 级以下 RCCEP 的发生率（≥2 级）	指标类型：	次要指标
Outcome：	The incidence rate of reverting to a level below RCCEP (≥ level 2)	Type：	Secondary indicator
测量时间点：	阿帕替尼开始用药至末次用药30天内	测量方法：	首次治疗出现 RCCEP≥2 级恢复到 1 级以下 RCCEP 的受试者所占的比例
Measure time point of outcome：	From the start of apatinib administration to within 30 days of the last dose	Measure method：	The proportion of subjects whose RCCEP (Recovery from Critical Cerebral Event Post-Stroke) levels improved from grade 2 to below grade 1 after the first treatment

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	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	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：	我们将根据试验方案设计专用的CRF表，用于收集所有疗效和安全性数据。授权的研究人员将依据源文件(如医疗病历、实验室报告)准确、及时地填写纸质CRF。所有修改均需签注姓名和日期。数据录入后，数据管理员将核查发起数据质疑，由研究中心人员进行解答和修正。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	We will design a dedicated CRF form according to the trial protocol to collect all efficacyand safety data. Authorized researchers will accurately and promptly fill out the paper CRFbased on source documents (such as medical records and laboratory reports). Allmodifications must be signed with a name and date. After data entry, the data manager willverify discrepancies and the research center staff will provide answers and corrections.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-06-01 15:27:34