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：	ChiCTR2600119904
最近更新日期： Date of Last Refreshed on：	2026-03-05 11:30:38
注册时间： Date of Registration：	2026-03-05 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	伊立替康脂质体（II）联合5-FU/LV、贝伐珠单抗、联合或不联合卡瑞利珠单抗一线治疗MSS/pMMR型转移性结直肠癌：一项随机化、开放标签、探索性临床研究
Public title：	Irinotecan Liposome (II) in Combination with 5-FU/LV, Bevacizumab, with or without Camrelizumab as First-Line Treatment for MSS/pMMR Metastatic Colorectal Cancer: A Randomized, Open-Label, Exploratory Clinical Study
注册题目简写：	伊立替康脂质体（II）联合5-FU/LV、贝伐珠单抗、联合或不联合卡瑞利珠单抗一线治疗MSS/pMMR型转移性结直肠癌
English Acronym：	Irinotecan Liposome (II) in Combination with 5-FU/LV, Bevacizumab, with or without Camrelizumab as First-Line Treatment for MSS/pMMR Metastatic Colorectal Cancer
研究课题的正式科学名称：	伊立替康脂质体（II）联合5-FU/LV、贝伐珠单抗、联合或不联合卡瑞利珠单抗一线治疗MSS/pMMR型转移性结直肠癌：一项随机化、开放标签、探索性临床研究
Scientific title：	Irinotecan Liposome (II) in Combination with 5-FU/LV, Bevacizumab, with or without Camrelizumab as First-Line Treatment for MSS/pMMR Metastatic Colorectal Cancer: A Randomized, Open-Label, Exploratory Clinical 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：	顾艳宏	研究负责人：	顾艳宏
Applicant：	GuYanhong	Study leader：	Gu Yanhong
申请注册联系人电话： Applicant telephone：	+86 25 6830 6714	研究负责人电话： Study leader's telephone：	+86 25 6830 6714
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：	guyanhong@njmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	guyanhong@njmu.edu.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：	江苏省南京市广州路30号	研究负责人通讯地址：	江苏省南京市广州路300号
Applicant address：	No. 30, Guangzhou Road, Nanjing City, Jiangsu Province	Study leader's address：	No. 300, Guangzhou Road, Nanjing City, Jiangsu 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：	江苏省人民医院
Applicant's institution：	Jiangsu Province Hospita
研究负责人所在单位：	江苏省人民医院（南京医科大学第一附属医院）
Affiliation of the Leader：	Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical 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：	2025-SR-554.A1	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：	南京医科大学第一附属医院（江苏省人民医院）伦理委员会
Name of the ethic committee：	Ethics Committee of the First Affiliated Hospital with Nanjing Medical university
伦理委员会批准日期： Date of approved by ethic committee：	2026-01-21 00:00:00
伦理委员会联系人：	王嘉楠
Contact Name of the ethic committee：	Wang JiaNan
伦理委员会联系地址：	江苏省南京市广州路300号
Contact Address of the ethic committee：	No. 300, Guangzhou Road, Nanjing City, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 25 6830 6360	伦理委员会联系人邮箱： Contact email of the ethic committee：	1096493017@qq.com

研究实施负责（组长）单位：

江苏省人民医院（南京医科大学第一附属医院）

Primary sponsor：

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

研究实施负责（组长）单位地址：

江苏省南京市广州路300号

Primary sponsor's address：

No. 300, Guangzhou Road, Nanjing City, Jiangsu 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)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	江苏省人民医院（南京医科大学第一附属医院）	具体地址：	江苏省南京市广州路300号
Institution hospital：	Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)	Address：	No. 300, Guangzhou Road, Nanjing City, Jiangsu Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-raised

研究疾病：

MSS/pMMR型转移性结直肠癌

Target disease：

MSS/pMMR metastatic colorectal cancer

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：

II期临床试验

Study phase：

2

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

主要研究目的 • 通过评估目标病灶客观缓解率（ORR），评价伊立替康脂质体（II）联合5-FU/LV、贝伐珠单抗、联合或不联合卡瑞利珠单抗一线治疗MSS/pMMR型转移性结直肠癌的有效性。次要研究目的 • 通过评估肿瘤缓解深度（DpR）、无进展生存期（PFS）、总生存期（OS）、疾病控制率（DCR），评价伊立替康脂质体（II）联合5-FU/LV、贝伐珠单抗、联合或不联合卡瑞利珠单抗一线治疗MSS/pMMR型转移性结直肠癌的有效性； • 评价伊立替康脂质体（II）联合5-FU/LV、贝伐珠单抗、联合或不联合卡瑞利珠单抗单抗一线治疗MSS/pMMR型转移性结直肠癌的安全性。

Objectives of Study：

Primary Objective: To evaluate the efficacy of irinotecan liposome (II) in combination with 5-FU/LV, bevacizumab, with or without camrelizumab as first-line treatment for MSS/pMMR metastatic colorectal cancer by assessing the objective response rate (ORR) in target lesions. Secondary Objectives: To evaluate the efficacy of irinotecan liposome (II) in combination with 5-FU/LV, bevacizumab, with or without camrelizumab as first-line treatment for MSS/pMMR metastatic colorectal cancer by assessing the depth of response (DpR), progression-free survival (PFS), overall survival (OS), and disease control rate (DCR); To evaluate the safety of irinotecan liposome (II) in combination with 5-FU/LV, bevacizumab, with or without camrelizumab as first-line treatment for MSS/pMMR metastatic colorectal cancer.

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. 年龄18岁 ~ 75岁（含两端界值，以签署知情同意书日期计算），性别不限；
2. 经病理组织学和/或细胞学诊断的不可手术切除的转移性结肠或直肠腺癌患者（根据UICC/AJCC TNM分期系统为IV期）；
3. 微卫星稳定型（MSS）或错配修复正常（pMMR）患者；
4. 当前疾病阶段未接受过任何系统抗肿瘤治疗（包括但不限于全身化疗、分子靶向药物治疗、免疫治疗、生物治疗以及其他研究治疗用药等）；若既往接受新辅助或辅助治疗，首次发现疾病复发/进展日期须与新辅助或辅助治疗末次给药日期间隔 ≥ 6个月；
5. 根据RECIST v1.1标准，至少具有1个可测量病灶，可测量病灶未接受过放疗或其他局部治疗，除非治疗完成后进展（即靶病灶应未接受过放疗等局部治疗，若位于既往放疗区域内的病灶，如果证实发生进展并符合RECIST v1.1标准，也可选做靶病灶）；
6. 美国东部肿瘤协作组（ECOG）体力状态评分0 ~ 1分；
7. 预期生存时间 ≥ 3个月；
8. 符合联合治疗的基本要求，包括外周血象基本正常，心、肝、肾功能无明显异常，心电图基本正常，即开始研究治疗前14天内受试者的器官功能水平及相关实验室指标必须符合下列要求（不包括在筛选期间使用任何血液成分及细胞生长因子）： 1)	血常规：中性粒细胞绝对计数（ANC）≥ 1.5 × 109/L；血小板计数（PLT）≥ 100 × 109/L；血红蛋白（Hb）≥ 90 g/L； 2)	血生化：血清白蛋白（ALB）≥ 25 g/L；谷丙转氨酶（ALT）/谷草转氨酶（AST）≤ 2.5倍正常值上限（ULN），如有肝转移则ALT/AST ≤ 5 × ULN；总胆红素（TBIL） ≤ 2 × ULN；血清肌酐（Cr） ≤ 1.5 × ULN，或根据Cockcroft-Gault公式计算的内生肌酐清除率≥ 60 mL/min； 3)	心脏功能：12-导联心电图正常或经研究者判断无临床意义的12-导联心电图异常（即，QTcF < 470 ms）；左室射血分数（LVEF）≥ 50%）； 4)	凝血功能：凝血酶原时间（PT）或活化部分凝血活酶时间（aPTT）≤ 1.5 × ULN、国际标准化比值（INR）≤ 1.5 × ULN（未接受过抗凝治疗；对于使用稳定剂量的抗凝治疗如低分子肝素或华法林且国际标准化比值[INR]在抗凝血剂的预期治疗范围内可以筛选）；
9. 育龄妇女必须在首次用药前7天内进行血清妊娠研究，且结果为阴性。育龄妇女受试者及其伴侣必须同意在试验期间和治疗结束后6个月内采取适当的方法避孕；
10.	自愿参加并签署知情同意书，并能依从研究访视计划和其它方案要求。

Inclusion criteria

1. Aged 18 to 75 years (inclusive, calculated from the date of signing the informed consent form), regardless of gender;
2. Patients with histopathologically and/or cytologically confirmed unresectable metastatic colon or rectal adenocarcinoma (Stage IV according to the UICC/AJCC TNM staging system);
3. Patients with microsatellite stable (MSS) or mismatch repair proficient (pMMR) status;
4. No prior systemic antitumor therapy for the current stage of disease (including but not limited to systemic chemotherapy, molecularly targeted therapy, immunotherapy, biotherapy, or other investigational treatments); if prior neoadjuvant or adjuvant therapy was received, the date of first disease recurrence/progression must be >= 6 months from the last dose of neoadjuvant or adjuvant therapy;
5. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; the measurable lesion must not have received prior radiotherapy or other local therapy unless progression has occurred after such treatment (i.e., target lesions should not have received prior local therapy such as radiotherapy; however, lesions situated in a previously irradiated area may be selected as target lesions if progression is confirmed and they meet RECIST v1.1 criteria);
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
7. Life expectancy of >= 3 months;
8. Adequate organ function meeting the basic requirements for combination therapy, including generally normal peripheral blood counts, no significant abnormalities in cardiac, hepatic, or renal function, and generally normal electrocardiogram results. Specifically, organ function and relevant laboratory parameters within 14 days prior to initiation of study treatment must meet the following requirements (without the use of any blood components or hematopoietic growth factors during the screening period):  Hematology: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelet count (PLT) >= 100 × 10^9/L; Hemoglobin (Hb) >= 90 g/L; Blood Biochemistry: Serum albumin (ALB) >= 25 g/L; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <= 2.5 × upper limit of normal (ULN), or ALT/AST <= 5 × ULN in the presence of liver metastases; Total bilirubin (TBIL) <= 2 × ULN; Serum creatinine (Cr) <= 1.5 × ULN, or calculated creatinine clearance >= 60 mL/min (using the Cockcroft-Gault formula); Cardiac Function: Normal 12-lead electrocardiogram (ECG) or 12-lead ECG abnormalities deemed clinically insignificant by the investigator (i.e., QTcF < 470 ms); Left ventricular ejection fraction (LVEF) >= 50%; Coagulation: Prothrombin time (PT) or activated partial thromboplastin time (aPTT) <= 1.5 × ULN; International normalized ratio (INR) <= 1.5 × ULN (for patients not receiving anticoagulation therapy; for those on stable doses of anticoagulants such as low-molecular-weight heparin or warfarin with an INR within the expected therapeutic range, screening is permitted);
9. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. Female patients of childbearing potential and their partners must agree to use adequate contraceptive methods during the trial and for 6 months after the completion of treatment;
10. Voluntary participation with signed informed consent, and ability to comply with the study visit schedule and other protocol requirements.

排除标准：

1. 肿瘤及治疗相关： 1)在筛选前5年内曾患有结直肠癌以外的恶性肿瘤（已治愈的皮肤基底细胞或鳞状上皮细胞癌、宫颈原位癌、研究者评估具有低风险转移和死亡风险的恶性肿瘤除外）； 2)已知经肿瘤组织经免疫组化方法证实为错配修复缺陷（dMMR）状态，或二代测序（NGS）/聚合酶链式反应（PCR）方法确认为微卫星高不稳定性（MSI-H）状态，且经研究者评估适合接受免疫检查点抑制剂治疗； 3)二代测序（NGS）/聚合酶链式反应（PCR）方法确认为BRAF V600E突变，对化疗预后不良的患者； 4)已知有中枢神经系统转移者，对于临床疑似中枢神经系统转移的患者，开始研究治疗前28天内必须进行增强电子计算机断层扫描（CT）或增强核磁共振（MRI）检查，排除中枢神经系统转移； 5)既往接受过免疫检查点抑制剂治疗的患者，包括抗PD-1、抗PD-L1、抗CTLA-4或任何细胞免疫治疗； 6)既往接受过伊立替康/伊立替康脂质体为基础的化疗； 7)开始研究治疗前14天内使用CYP3A4、CYP2C8和UGT1A1强抑制剂/诱导剂； 8)开始研究治疗前4周内参加过其他药物临床试验，除非是观察性（非干预性）临床研究或者干预性临床研究随访；
2. 病史或合并疾病： 1) 临床记录显示有严重的胃肠功能紊乱（包括出血、梗阻；NCI-CTCAE v5.0 > 2级的炎症；NCI-CTCAE v5.0 > 1级的腹泻），或经研究者判断可能会影响药物的摄入、转运或吸收的其他情况（包括无法吞咽；小肠切除术后或全胃切除等）； 2) 需要临床干预的胸腔积液或腹水（NCI-CTCAE v5.0 ≥ 2级）； 3) 存在妨碍试验药物治疗的严重合并症： a) 研究者认为会影响受试者接受研究方案治疗能力的未受控制的严重医学疾病，例如合并严重的内科疾病，包括严重心脏病、脑血管病、未控制的糖尿病、未控制的高血压、活动性消化性溃疡等； b) 筛选前一年内发生过动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作）、深静脉血栓（因前期化疗行静脉置管引发静脉血栓经研究者判断已痊愈者除外）及肺栓塞等； c) 影像学显示肿瘤已侵犯重要血管周围或经研究者判断患者肿瘤在治疗期间有极高可能侵袭重要血管而引起致命大出血的情况； d) 既往有间质性肺病，或有（非感染性）肺炎且需口服或静脉类固醇激素； e) 有未能良好控制的心脏临床症状或疾病，如：纽约心脏病协会（NYHA）2级以上心力衰竭；不稳定型心绞痛；6个月内发生过心肌梗死；有临床意义、需要治疗或干预的室上性或室性心律失常； f) 丙型肝炎病毒（HCV）抗体阳性或人免疫缺陷病毒（HIV）抗体阳性； 4) 筛选前4周内发生过严重感染（NCI-CTCAE v5.0 > 2级），如需要住院治疗的严重肺炎、菌血症、感染并发症等；开始研究治疗前2周内存在感染的症状和体征需要静脉使用抗生素治疗（预防性使用抗生素的情况除外）。
3. 其他： 1) 已知对任意试验药物或其辅料过敏或不能耐受，或存在任一试验药物禁忌症； 2) 研究者认为应排除在本研究之外，例如经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如存在其他的严重疾病（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、会影响到受试者的安全或资料及样品的收集的。

Exclusion criteria：

1. Tumor- and Treatment-Related: (1) History of another malignancy within 5 years prior to screening, except for curatively treated basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies assessed by the investigator to have a low risk of metastasis and death; (2) Known tumor tissue status of mismatch repair deficient (dMMR) confirmed by immunohistochemistry, or microsatellite instability-high (MSI-H) confirmed by next-generation sequencing (NGS)/polymerase chain reaction (PCR), and assessed by the investigator as suitable for treatment with immune checkpoint inhibitors; (3) Confirmed BRAF V600E mutation by NGS/PCR, indicating a poor prognosis with chemotherapy; (4) Known central nervous system (CNS) metastases; for patients with clinically suspected CNS metastases, contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) must be performed within 28 days prior to initiation of study treatment to exclude CNS metastases; (5) Prior treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or any cellular immunotherapy; (6) Prior treatment with irinotecan/irinotecan liposome-based chemotherapy; (7) Use of strong inhibitors or inducers of CYP3A4, CYP2C8, and UGT1A1 within 14 days prior to initiation of study treatment; (8) Participation in another clinical trial of a drug within 4 weeks prior to initiation of study treatment, except for observational (non-interventional) studies or follow-up periods of interventional studies; 2. Medical History or Comorbid Conditions: (1) Clinically documented severe gastrointestinal disorders (including bleeding, obstruction; inflammation > Grade 2 per NCI-CTCAE v5.0; diarrhea > Grade 1 per NCI-CTCAE v5.0), or other conditions judged by the investigator that might affect the ingestion, transit, or absorption of the study drug (including inability to swallow; status post small bowel resection or total gastrectomy); (2) Pleural effusion or ascites requiring clinical intervention (NCI-CTCAE v5.0 >= Grade 2); (3) Presence of severe comorbidities that would interfere with the study drug treatment: 1) Uncontrolled serious medical conditions judged by the investigator that would affect the subject's ability to receive the study regimen, such as severe concomitant internal diseases including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, active peptic ulcer disease, etc.; 2) Occurrence of arterial/venous thrombotic events within one year prior to screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (excluding venous thrombosis caused by venous catheterization for prior chemotherapy that has resolved as judged by the investigator), and pulmonary embolism; 3) Imaging evidence showing tumor invasion of major blood vessels, or patients judged by the investigator to have a very high risk of tumor invading major blood vessels during treatment, potentially leading to fatal massive hemorrhage; 4) History of interstitial lung disease or (non-infectious) pneumonitis requiring oral or intravenous corticosteroids; 5) Poorly controlled cardiac clinical symptoms or diseases, such as: New York Heart Association (NYHA) Class II or greater heart failure; unstable angina; myocardial infarction within the past 6 months; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 6) Positive hepatitis C virus (HCV) antibody or positive human immunodeficiency virus (HIV) antibody; (4) Occurrence of severe infection (NCI-CTCAE v5.0 > Grade 2) within 4 weeks prior to screening, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; presence of signs or symptoms of infection requiring intravenous antibiotic use (excluding prophylactic antibiotic use) within 2 weeks prior to initiation of study treatment. 3. Other: (1) Known allergy or intolerance to any of the investigational drugs or their excipients, or presence of any contraindication to any of the investigational drugs; (2) Any other condition deemed by the investigator to warrant exclusion from the study, such as other severe diseases (including mental illnesses) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that, in the investigator's judgment, might compromise the safety of the subject or the collection of data and samples, potentially leading to premature discontinuation from the study.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-03-15 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：	组A：伊立替康脂质体（II）+5-FU/LV+贝伐珠单抗	样本量：	75
Group：	Arm A: Irinotecan Liposome (II) + 5-FU/LV + Bevacizumab	Sample size：	75
干预措施：	伊立替康脂质体（II）+5-FU/LV+贝伐珠单抗	干预措施代码：
Intervention：	Irinotecan Liposome (II) + 5-FU/LV + Bevacizumab	Intervention code：

组别：	组B：伊立替康脂质体（II）+5-FU/LV+贝伐珠单抗+卡瑞利珠单抗	样本量：	75
Group：	Arm B: Irinotecan Liposome (II) + 5-FU/LV + Bevacizumab + Camrelizumab	Sample size：	75
干预措施：	伊立替康脂质体（II）+5-FU/LV+贝伐珠单抗+卡瑞利珠单抗	干预措施代码：
Intervention：	Irinotecan Liposome (II) + 5-FU/LV + Bevacizumab + Camrelizumab	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	江苏省人民医院（南京医科大学第一附属医院）	单位级别：	三级甲等
Institution hospital：	Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	常州市第一人民医院	单位级别：	三级甲等
Institution hospital：	Changzhou First People's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	客观缓解率, ORR	指标类型：	主要指标
Outcome：	Objective response rate, ORR	Type：	Primary indicator
测量时间点：	每8周检查一次	测量方法：	将每8周（±7天）进行一次影像学检查（CT或MRI），根据RECIST v1.1标准评估肿瘤反应。
Measure time point of outcome：	Tumor assessment will be performed every 8 weeks(+-7days)	Measure method：	Radiologic imaging (CT or MRI) will be performed every 8 weeks (+-7days) to assess tumor response according to RECIST v1.1 criteria.

指标中文名：	总生存期, OS	指标类型：	次要指标
Outcome：	Overall survival, OS	Type：	Secondary indicator
测量时间点：	生存状态在每次计划访视时（每8周）及治疗结束后长期随访期间（每2个月）进行评估。	测量方法：	OS定义为从随机化至任何原因死亡的时间。失访或在数据截止日仍生存的患者，以最后已知生存日期进行删失。生存状态在每次计划访视时（每8周）及治疗结束后长期随访期间（每2个月）进行评估。
Measure time point of outcome：	at each scheduled visit (every 8 weeks) and during long-term follow-up (every 2 months) after treatm	Measure method：	Overall survival (OS) was defined as the time from randomization to death from any cause. Patients who were lost to follow-up or alive at the data cutoff date were censored at the last known date they were alive. Survival status was assessed at each scheduled visit (every 8 weeks) and during long-term follow-up (every 2 months) after treatment discontinuation.

指标中文名：	疾病控制率, DCR	指标类型：	次要指标
Outcome：	Disease control rate, DCR	Type：	Secondary indicator
测量时间点：	每8周检查一次	测量方法：	将每8周（±7天）进行一次影像学检查（CT或MRI），根据RECIST v1.1标准评估肿瘤反应。
Measure time point of outcome：	Tumor assessment will be performed every 8 weeks(+-7days)	Measure method：	Radiologic imaging (CT or MRI) will be performed every 8 weeks(+-7days) to assess tumor response according to RECIST v1.1 criteria.

指标中文名：	反应深度, DpR	指标类型：	次要指标
Outcome：	Depth of Response (DpR)	Type：	Secondary indicator
测量时间点：	每8周检查一次	测量方法：	将每8周（±7天）进行一次影像学检查（CT或MRI），根据RECIST v1.1标准评估肿瘤反应。
Measure time point of outcome：	Tumor assessment will be performed every 8 weeks(+-7days)	Measure method：	Radiologic imaging (CT or MRI) will be performed every 8 weeks (+-7days)to assess tumor response according to RECIST v1.1 criteria.

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：	常规随访	测量方法：	生命体征、实验室检查指标（血常规、血尿便常规、血生化、凝血功能）、ECG、心脏彩超、不良事件，其中不良事件根据NCI-CTCAE v5.0标准判断。的测量时间点
Measure time point of outcome：	assessed at each scheduled visit	Measure method：	Safety assessments included monitoring of vital signs, laboratory tests (complete blood count [CBC], routine blood, urine, and stool tests, blood biochemistry, coagulation function), 12-lead electrocardiogram (ECG), echocardiography, and adverse events (AEs). AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

指标中文名：	无进展生存期, PFS	指标类型：	次要指标
Outcome：	Progression Free Survival, PFS	Type：	Secondary indicator
测量时间点：	在基线、之后每8周（±7天）进行肿瘤评估，直至出现影像学疾病进展、死亡或开始后续抗肿瘤治疗（以先发生者为准）。PFS定义为从随机化至首次记录到RECIST v1.1定义的疾病进展或任何原因死亡的时间。	测量方法：	在基线、之后每8周（±7天）进行肿瘤评估，直至出现影像学疾病进展、死亡或开始后续抗肿瘤治疗（以先发生者为准）。PFS定义为从随机化至首次记录到RECIST v1.1定义的疾病进展或任何原因死亡的时间。
Measure time point of outcome：	Tumor assessments were performed at baseline, then every 8 weeks (+-7 days) thereafter until radiogr	Measure method：	Tumor assessments were performed at baseline, then every 8 weeks (+- 7 days) thereafter until radiogr

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	粪便	组织：
Sample Name：	Stool sample	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：	血液	组织：
Sample Name：	Blood samples	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：	尿液	组织：
Sample Name：	Urine sample	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）：

随机系统

Randomization Procedure (please state who generates the random number sequence and by what method)：

A stratified permuted-block randomization was performed

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：	开放标签
Blinding：	Open-label study

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：	EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	EDC
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-03-05 11:22:28