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：	ChiCTR2600124310
最近更新日期： Date of Last Refreshed on：	2026-05-10 21:41:14
注册时间： Date of Registration：	2026-05-10 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	达尔西利联合或不联合卡瑞利珠单抗用于至少经过两种含标准方案的系统治疗后进展/不耐受的晚期肝内胆管癌患者：一项前瞻性、双队列、Ⅰb/Ⅱ 期临床研究
Public title：	Dalpiciclib with or without Camrelizumab in patients with advanced Intrahepatic Cholangiocarcinoma after failure or intolerance of first-line therapy: A prospective, double-Cohort, phase Ⅰb/Ⅱ study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	达尔西利联合或不联合卡瑞利珠单抗用于至少经过两种含标准方案的系统治疗后进展/不耐受的晚期肝内胆管癌患者：一项前瞻性、双队列、Ⅰb/Ⅱ 期临床研究
Scientific title：	Dalpiciclib with or without Camrelizumab in patients with advanced Intrahepatic Cholangiocarcinoma after failure or intolerance of first-line therapy: A prospective, double-Cohort, phase Ⅰb/Ⅱ study
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：	徐立	研究负责人：	徐立
Applicant：	Xu Li	Study leader：	Xu Li
申请注册联系人电话： Applicant telephone：	+86 20 8734 3582	研究负责人电话： Study leader's telephone：	+86 20 8734 3582
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：	xuli@sysucc.org.cn	研究负责人电子邮件： Study leader's E-mail：	xuli@sysucc.org.cn
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：	广东省广州市越秀区东风东路651号	研究负责人通讯地址：	广东省广州市越秀区东风东路651号
Applicant address：	No. 651 Dongfeng East Road, Yuexiu District, Guangzhou City, Guangdong Province	Study leader's address：	No. 651 Dongfeng East Road, Yuexiu District, Guangzhou City, Guangdong 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：	中山大学肿瘤防治中心
Applicant's institution：	Sun Yat-sen University Cancer Center
研究负责人所在单位：	中山大学肿瘤防治中心
Affiliation of the Leader：	Sun Yat-sen University Cancer Center

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：	B2025-876-01	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：	中山大学肿瘤防治中心、中山大学附属肿瘤医院伦理委员会
Name of the ethic committee：	Institutional Review Board of Sun-Yat sen University Cancer Center
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：	潘旭芝
Contact Name of the ethic committee：	Pan XuZhi
伦理委员会联系地址：	广东省广州市越秀区东风东路651号
Contact Address of the ethic committee：	No. 651 Dongfeng East Road, Yuexiu District, Guangzhou City, Guangdong Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 20 87343009	伦理委员会联系人邮箱： Contact email of the ethic committee：	panxzh@sysucc.org.cn

研究实施负责（组长）单位：

中山大学肿瘤防治中心

Primary sponsor：

Sun Yat-sen University Cancer Center

研究实施负责（组长）单位地址：

广东省广州市越秀区东风东路651号

Primary sponsor's address：

No. 651 Dongfeng East Road, Yuexiu District, Guangzhou City, Guangdong 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)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	中山大学肿瘤防治中心	具体地址：	广东省广州市越秀区东风东路651号
Institution hospital：	Sun Yat-sen University Cancer Center	Address：	No. 651 Dongfeng East Road, Yuexiu District, Guangzhou City, Guangdong Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected topic (self-funded)

研究疾病：

肝内胆管细胞癌

Target disease：

Intrahepatic cholangiocarcinoma

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：

I期+II期

Study phase：

1-2

研究设计：

非随机对照试验

Study design：

Non randomized control

研究目的：

本研究为双队列、Ib/II期临床研究，拟观察和评价达尔西利联合或不联合卡瑞利珠单抗用于至少经过两种含标准方案的系统治疗后进展或不耐受的肝内胆管癌患者的有效性和安全性。

Objectives of Study：

This study is a dual-cohort, phase Ib/II clinical study to observe and evaluate the efficacy and safety of darcilib with or without camrelizumab in patients with intrahepatic cholangiocarcinoma who have progressed or are intolerant to at least two standard regimens.

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. The patient voluntarily participated in this study and signed the informed consent form;
2. Age >= 18 years (calculated from the date of signing the informed consent form), both men and women are eligible;
3. Liver intrahepatic cholangiocarcinoma confirmed by pathological histology or cytological examination, which cannot be surgically removed, relapsed or metastasized, and has progressed or been intolerant to previous at least two systemic treatments (progression within 6 months after neoadjuvant/adoptive therapy can be regarded as failure of first-line treatment);
4. Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1;
5. Expected survival period is more than 3 months;
6. At least one measurable lesion (according to RECIST v1.1 requirements, the measurable lesion on spiral CT or MR scan has a long diameter >= 10 mm or the short diameter of enlarged lymph nodes >= 15 mm; lesions that have progressed or relapsed after local treatment can be regarded as target lesions according to the RECIST v1.1 standard);
7. Basic organ functions are basically normal, without severe abnormalities in blood, heart, lung, liver, kidney, bone marrow and immune deficiency diseases;
8. Recovery from adverse events of previous anti-tumor treatment to baseline, or rated <= 1 level according to the NCI-CTCAE v5.0 of the US National Cancer Institute (excluding alopecia and vitiligo; stable or <= 2 levels of neuropathy induced by previous anti-tumor treatment);
9. Male or fertile female subjects take effective contraceptive measures during the treatment period and within 90 days after the last medication.

排除标准：

1.5年内或同时患有除肝内胆管癌之外的其它活动性恶性肿瘤。不包括已治愈的局限性肿瘤，如皮肤基底细胞癌、皮肤鳞癌、表浅膀胱癌、前列腺原位癌、宫颈原位癌、乳腺原位癌等； 2.在开始研究治疗之前28天或5个已知药物半衰期（以时间长者为准）内接受过抗肿瘤治疗，包括系统性化疗、免疫治疗、激素治疗、靶向药治疗或研究药物； 3.在研究药物首次给药前2周内进行过大手术、化学治疗、放射治疗、任何研究性药物或其他抗癌治疗； 4.既往接受过CDK4/6抑制剂药物治疗； 5.存在中枢神经系统疾病或临床不稳定的肿瘤中枢神经系统（CNS）转移。临床稳定的肿瘤CNS转移是指MRI或CT扫描确认疾病稳定>=3个月，和/或经低剂量类固醇激素、抗癫痫和其它症状缓解药物病情可控； 6.目前患有无法控制的心脑血管疾病或有既往病史； 7.存在角膜或视网膜严重疾病，包括但不限于：大泡性/带状角膜病、角膜结膜炎、角膜磨损、角膜炎/溃疡等； 8.存在如甲状旁腺障碍、肿瘤溶解综合征等导致钙磷稳态变化的病史或现病史； 9.既往有广泛组织钙化史和/或当前存在广泛组织钙化证据； 10.存在活动性的肝胆疾病，如病毒性肝炎、肝硬化、未治疗或存在腹腔镜检查后或支架放置并发症，包括但不限于活动性胆管炎，胆汁瘤、脓肿等；有HBV/HCV病毒携带的患者要求入组前已接受抗病毒治疗，且HBV-DNA/HCV-RNA下降10倍以上； 11.不能吞咽药片、吸收不良综合症，或存在严重的胃肠道疾病，研究者临床判断认为可能影响研究药物的吸收、代谢或消除的情况； 12.已知存在的遗传性或获得性出血（如凝血功能障碍）或血栓倾向，如血友病病人；目前正在或近期（研究治疗开始前10天内）曾出于治疗目的使用全剂量口服或注射抗凝药物或溶栓药物（允许预防性使用小剂量阿司匹林、低分子肝素）； 13.合并不宜接受免疫治疗的其他疾病，包括且不限于系统性红斑狼疮、强直性脊柱炎等免疫系统疾病，以及需要长期持续口服类固醇激素治疗者； 14.严重、未愈合或裂开的伤口以及活动期溃疡或未经治疗的骨折； 15.已知活动性期HBV感染(HBV DNA> 2000 IU/mL且AST, ALT升高)、活动性期HCV感染（HCV RNA阳性且未接受抗病毒治疗）感染、HIV感染阳性病史或已知的获得性免疫缺陷综合征（Acquired Immune Deficiency Syndrome，AIDS）； 16.女性受试者处于妊娠期或哺乳期； 17.末次使用强效CYP3A抑制剂或CYP3A诱导剂距离首次试验用药时间不足5个半衰期，或者计划参与本研究期间同时服用强效CYP3A抑制作用或诱导作用的药物或食物； 18.已知对研究药物辅料过敏； 19.经研究者判断，患者有其他可能影响研究结果或导致本研究被迫中途终止的因素，如酗酒、药物滥用、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，伴有家庭或社会等因素，会影响到患者的安全； 20.基因检测结果提示存在其他可应用的靶向药物

Exclusion criteria：

1. Within 5 years or simultaneously having other active malignant tumors other than intrahepatic cholangiocarcinoma. This does not include cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostatic carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.; 2. Within 28 days before starting the treatment or within 5 known drug half-lives (whichever is longer), received anti-tumor treatment, including systemic chemotherapy, immunotherapy, hormone therapy, targeted drug therapy or the study drug; 3. Within 2 weeks before the first administration of the study drug, undergone major surgery, chemotherapy, radiotherapy, any investigational drug or other anti-cancer treatment; 4. Previously received CDK4/6 inhibitor drug treatment; 5. Have central nervous system diseases or clinically unstable central nervous system (CNS) metastases of tumors. Clinically stable CNS metastases of tumors refers to confirmed disease stability >= 3 months by MRI or CT scan, and/or controlled by low-dose steroid hormones, anti-epileptic and other symptom relief drugs; 6. Currently have uncontrollable cardiovascular and cerebrovascular diseases or a previous history; 7. Have severe corneal or retinal diseases, including but not limited to: bullous/striped corneal disease, corneal conjunctivitis, corneal abrasion, keratitis/ulcer, etc.; 8. Have a history or current condition of diseases causing changes in calcium and phosphorus homeostasis, such as parathyroid disorders, tumor lysis syndrome, etc.; 9. Have a history of extensive tissue calcification or current evidence of extensive tissue calcification; 10. Have active liver and gallbladder diseases, such as viral hepatitis, liver cirrhosis, untreated or complications after laparoscopic examination or stent placement, including active cholangitis, cholangiocarcinoma, abscess, etc.; Patients with HBV/HCV virus carriers are required to have received antiviral treatment before enrollment, and HBV-DNA/HCV-RNA should decrease by more than 10 times; 11. Unable to swallow pills, have malabsorption syndrome, or have severe gastrointestinal diseases, and the investigator clinically determines that it may affect the absorption, metabolism or elimination of the study drug; 12. Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombosis tendency, such as hemophilia patients; Currently using or within 10 days before the start of the treatment, have used full-dose oral or injectable anticoagulant drugs or thrombolytic drugs (allowing for preventive use of low-dose aspirin, low-molecular-weight heparin); 13. Have other diseases that are not suitable for immunotherapy, including but not limited to systemic lupus erythematosus, ankylosing spondylitis, etc. immune system diseases, and those requiring long-term continuous oral steroid hormone treatment; 14. Severe, non-healed or open wounds, active ulcers or untreated fractures; 15. Known active HBV infection (HBV DNA > 2000 IU/mL and elevated AST, ALT), active HCV infection (HCV RNA positive and not receiving antiviral treatment), positive HIV history or known acquired immune deficiency syndrome (Acquired Immune Deficiency Syndrome, AIDS); 16. Female subjects are in the pregnancy period or lactation period; 17. The time interval between the last use of a potent CYP3A inhibitor or CYP3A inducer and the first trial medication is less than 5 half-lives, or plan to take drugs or foods with potent CYP3A inhibitory or inducing effects during the study period; 18. Known to be allergic to the excipients of the study drug; 19. Based on the researchers' assessment, the patient has other factors that may affect the research results or cause the study to be prematurely terminated. These include alcohol abuse, drug addiction, other serious diseases (including mental illnesses) that require combined treatment, significant laboratory test abnormalities, and factors such as family or social circumstances that could endanger the patient's safety. 20. The genetic test results indicate the presence of other applicable targeted drugs.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-11 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：	队列 1（达尔西利单药）	样本量：	10
Group：	Queue 1 (Darsilim Single Drug)	Sample size：	10
干预措施：	接受达尔西利单药治疗。达尔西利推荐剂量 150 mg，每日口服，D1-D21，以 4 周（28 天）为一个周期	干预措施代码：
Intervention：	Receive darzalex monotherapy. The recommended dose of darzalex is 150 mg, taken orally daily from D1 to D21. Each cycle lasts for 4 weeks (28 days).	Intervention code：

组别：	队列 2（达尔西利联合卡瑞利珠单抗）	样本量：	32
Group：	Queue 2 (Dasilei combined with Carlimabucilumab)	Sample size：	32
干预措施：	接受达尔西利单药或达尔西利联合卡瑞利珠单抗治疗。研究治疗以 4 周（28天）为一个周期，达尔西利推荐剂量 150 mg，每日口服，D1-D21；卡瑞利珠单抗 200 mg，静脉滴注，每 2 周给药 1 次。	干预措施代码：
Intervention：	Receive treatment with darzalex alone or in combination with carlimab. The study treatment is conducted in 4-week (28-day) cycles. The recommended dose of darzalex is 150 mg, taken orally daily from D1 to D21; carlimab 200 mg, administered by intravenous drip, given once every 2 weeks.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	中山大学肿瘤防治中心	单位级别：	三级甲等
Institution hospital：	Sun Yat-sen University Cancer Center	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	疾病控制率	指标类型：	主要指标
Outcome：	Disease control ratio，DCR	Type：	Primary indicator
测量时间点：	用药第二周期开始，每2个周期测量1次。	测量方法：	根据RECIST v1.1标准进行，应评估和记录所有的可测量及可评价的肿瘤病灶。基线评估包括胸、腹及有病灶部位的增强CT扫描，如对增强CT造影剂过敏，则可进行胸部CT平扫+腹部MRI扫描；骨扫描仅在有临床指征时进行。治疗期评估以筛选期作为基线，每2个疗程（9-12周）进行一次，在有临床指征时另外进行扫描。
Measure time point of outcome：	The second cycle of medication begins, measured 1 time every 2 cycles.	Measure method：	According to RECIST v1.1 criteria, all measurable and evaluable tumor lesions should be evaluated and documented. Baseline evaluation includes enhanced CT scan of the chest, abdomen and lesional areas, if allergic to enhanced CT contrast agent, chest CT plain scan + abdominal MRI scan can be performed; Bone scans are performed only when clinically indicated. Treatment period assessments are performed every 2 sessions (9-12 weeks) with the screening period as a baseline, and additional scans are

指标中文名：	客观缓解率	指标类型：	主要指标
Outcome：	Objective Response Rate，ORR	Type：	Primary indicator
测量时间点：	用药第二周期开始，每2个周期测量1次。	测量方法：	根据RECIST v1.1标准进行，应评估和记录所有的可测量及可评价的肿瘤病灶。基线评估包括胸、腹及有病灶部位的增强CT扫描，如对增强CT造影剂过敏，则可进行胸部CT平扫+腹部MRI扫描；骨扫描仅在有临床指征时进行。治疗期评估以筛选期作为基线，每2个疗程（9-12周）进行一次，在有临床指征时另外进行扫描。
Measure time point of outcome：	The second cycle of medication begins, measured 1 time every 2 cycles.	Measure method：	According to RECIST v1.1 criteria, all measurable and evaluable tumor lesions should be evaluated and documented. Baseline evaluation includes enhanced CT scan of the chest, abdomen and lesional areas, if allergic to enhanced CT contrast agent, chest CT plain scan + abdominal MRI scan can be performed; Bone scans are performed only when clinically indicated. Treatment period assessments are performed every 2 sessions (9-12 weeks) with the screening period as a baseline, and additional scans are

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：	用药第二周期开始，每2个周期测量1次。	测量方法：	根据RECIST v1.1标准进行，应评估和记录所有的可测量及可评价的肿瘤病灶。基线评估包括胸、腹及有病灶部位的增强CT扫描，如对增强CT造影剂过敏，则可进行胸部CT平扫+腹部MRI扫描；骨扫描仅在有临床指征时进行。治疗期评估以筛选期作为基线，每2个疗程（9-12周）进行一次，在有临床指征时另外进行扫描。
Measure time point of outcome：	The second cycle of medication begins, measured 1 time every 2 cycles.	Measure method：	According to RECIST v1.1 criteria, all measurable and evaluable tumor lesions should be evaluated and documented. Baseline evaluation includes enhanced CT scan of the chest, abdomen and lesional areas, if allergic to enhanced CT contrast agent, chest CT plain scan + abdominal MRI scan can be performed; Bone scans are performed only when clinically indicated. Treatment period assessments are performed every 2 sessions (9-12 weeks) with the screening period as a baseline, and additional scans are

指标中文名：	缓解持续时间	指标类型：	次要指标
Outcome：	Duration of Response，DoR	Type：	Secondary indicator
测量时间点：	用药第二周期开始，每2个周期测量1次。	测量方法：	根据RECIST v1.1标准进行，应评估和记录所有的可测量及可评价的肿瘤病灶。基线评估包括胸、腹及有病灶部位的增强CT扫描，如对增强CT造影剂过敏，则可进行胸部CT平扫+腹部MRI扫描；骨扫描仅在有临床指征时进行。治疗期评估以筛选期作为基线，每2个疗程（9-12周）进行一次，在有临床指征时另外进行扫描。
Measure time point of outcome：	The second cycle of medication begins, measured 1 time every 2 cycles.	Measure method：	According to RECIST v1.1 criteria, all measurable and evaluable tumor lesions should be evaluated and documented. Baseline evaluation includes enhanced CT scan of the chest, abdomen and lesional areas, if allergic to enhanced CT contrast agent, chest CT plain scan + abdominal MRI scan can be performed; Bone scans are performed only when clinically indicated. Treatment period assessments are performed every 2 sessions (9-12 weeks) with the screening period as a baseline, and additional scans are

指标中文名：	剂量限制性毒性	指标类型：	次要指标
Outcome：	Dose-limiting toxicity, DLT	Type：	Secondary indicator
测量时间点：	用药第二周期开始，每个周期测量1次。	测量方法：	依据NCI-CTCAE v5.0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；生命体征、心电图和实验室检查异常等。
Measure time point of outcome：	The second cycle of medication begins, measured 1 time every cycle.	Measure method：	The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) were judged according to NCI-CTCAE v5.0 criteria. abnormal vital signs, electrocardiograms, and laboratory tests, etc.

指标中文名：	至缓解时间	指标类型：	次要指标
Outcome：	Time to Response, TTR	Type：	Secondary indicator
测量时间点：	用药第二周期开始，每2个周期测量1次。	测量方法：	根据RECIST v1.1标准进行，应评估和记录所有的可测量及可评价的肿瘤病灶。基线评估包括胸、腹及有病灶部位的增强CT扫描，如对增强CT造影剂过敏，则可进行胸部CT平扫+腹部MRI扫描；骨扫描仅在有临床指征时进行。治疗期评估以筛选期作为基线，每2个疗程（9-12周）进行一次，在有临床指征时另外进行扫描。
Measure time point of outcome：	The second cycle of medication begins, measured 1 time every 2 cycles.	Measure method：	According to RECIST v1.1 criteria, all measurable and evaluable tumor lesions should be evaluated and documented. Baseline evaluation includes enhanced CT scan of the chest, abdomen and lesional areas, if allergic to enhanced CT contrast agent, chest CT plain scan + abdominal MRI scan can be performed; Bone scans are performed only when clinically indicated. Treatment period assessments are performed every 2 sessions (9-12 weeks) with the screening period as a baseline, and additional scans are

指标中文名：	最佳缓解	指标类型：	次要指标
Outcome：	Best overall response，BOR	Type：	Secondary indicator
测量时间点：	用药第二周期开始，每2个周期测量1次。	测量方法：	根据RECIST v1.1标准进行，应评估和记录所有的可测量及可评价的肿瘤病灶。基线评估包括胸、腹及有病灶部位的增强CT扫描，如对增强CT造影剂过敏，则可进行胸部CT平扫+腹部MRI扫描；骨扫描仅在有临床指征时进行。治疗期评估以筛选期作为基线，每2个疗程（9-12周）进行一次，在有临床指征时另外进行扫描。
Measure time point of outcome：	The second cycle of medication begins, measured 1 time every 2 cycles.	Measure method：	According to RECIST v1.1 criteria, all measurable and evaluable tumor lesions should be evaluated and documented. Baseline evaluation includes enhanced CT scan of the chest, abdomen and lesional areas, if allergic to enhanced CT contrast agent, chest CT plain scan + abdominal MRI scan can be performed; Bone scans are performed only when clinically indicated. Treatment period assessments are performed every 2 sessions (9-12 weeks) with the screening period as a baseline, and additional scans are

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：

标本中文名：	肿瘤病理组织	组织：
Sample Name：	Tumoral pathological tissue	Tissue：
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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age		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：	本研究的临床试验数据管理的工作由研究者及研究团队负责，进行研究数据的收集与管理;病例报告表（CRF）的填写：CRF 由研究者或数据录入人员进行填写。CRF 应当及时填写，并确保填写的数据可以从原始记录中被溯源。在CRF 中进行数据修改时，需填写数据修改的原因。研究者或其授权的人员需要对CRF 数据的真实性、完整性和及时性进行确认。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The clinical trial data management of this study is the responsibility of the investigator and the research team to collect and manage the research data. Completion of the Case Report Form (CRF): The CRF is completed by the investigator or data entry personnel. CRFs should be completed in a timely manner and ensure that the data filled in can be traced back to the original records. When making data modifications in the CRF, you need to enter the reason for the data modification. The investigator or his authorized personnel need to confirm the authenticity, completeness, and timeliness of the CRF data.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-05-10 21:41:08