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：	ChiCTR2600122531
最近更新日期： Date of Last Refreshed on：	2026-04-14 17:55:52
注册时间： Date of Registration：	2026-04-14 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	阿得贝利单抗联合靶向及化疗用于不可切除MSS型结肠癌肝转移患者转化治疗的单臂、单中心、II期探索性研究
Public title：	A Single-Arm, Single-Center, Phase II Exploratory Study of Adbelimab in Combination with Targeted Therapy and Chemotherapy for the Conversion Therapy of Patients with Unresectable MSS Colorectal Cancer with Liver Metastases
注册题目简写：
English Acronym：
研究课题的正式科学名称：	阿得贝利单抗联合靶向及化疗用于不可切除MSS型结肠癌肝转移患者转化治疗的单臂、单中心、II期探索性研究
Scientific title：	A Single-Arm, Single-Center, Phase II Exploratory Study of Adbelimab in Combination with Targeted Therapy and Chemotherapy for the Conversion Therapy of Patients with Unresectable MSS Colorectal Cancer with Liver Metastases
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：	孙跃明	研究负责人：	孙跃明
Applicant：	Yueming Sun	Study leader：	Yueming Sun
申请注册联系人电话： Applicant telephone：	+86 135 0518 8397	研究负责人电话： Study leader's telephone：	+86 135 0518 8397
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：	sunyueming@njmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	sunyueming@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：	江苏省南京市鼓楼区广州路300号	研究负责人通讯地址：	江苏省南京市鼓楼区广州路300号
Applicant address：	No. 300, Guangzhou Road, Gulou District, Nanjing City, Jiangsu Province	Study leader's address：	No. 300, Guangzhou Road, Gulou District, 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(南京医科大学第一附属医院)
Applicant's institution：	Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
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-712	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：	2025-11-26 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：

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	市(区县)：	南京市
Country：	China	Province：	Jiangsu	City：	Nanjing
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 funds

研究疾病：

结直肠癌

Target disease：

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：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

拟探索阿得贝利单抗联合靶向及化疗用于不可切除结肠癌肝转移患者转化治疗的有效性及安全性，以期更多晚期结直肠癌患者带来新的治疗策略。

Objectives of Study：

To investigate the efficacy and safety of adebelizumab in combination with targeted therapy and chemotherapy as a translational treatment for patients with unresectable colorectal cancer with liver metastases, with the goal of providing a new treatment strategy for more patients with advanced 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：

Inclusion criteria

1. The patient has a full understanding of this study, has voluntarily signed the informed consent form, demonstrates good compliance, and is willing to cooperate with follow-up;
2. Age >= 18 years and <= 75 years;
3. ECOG performance status of 0–1;
4. Expected survival of >= 12 weeks;
5. Patients with histologically or pathologically confirmed colorectal adenocarcinoma;
6. Diagnostic records from PET/CT, CT, MRI, or intraoperative exploration indicate evidence of localized liver metastases (histological confirmation of liver metastases is not required);
7. MSS-type mCRC;
8. The patient has at least one measurable liver metastatic lesion (according to RECIST 1.1 criteria);
9. No prior chemotherapy for liver metastases;
10. The primary colorectal cancer site shows no symptoms of bleeding, obstruction, or perforation; the primary colorectal cancer site is resectable or has been resected; patients whose liver metastases were initially not resectable as R0 or whose residual liver volume is <=40% after resection;
11. Normal function of major organs, meeting the following criteria:
(1) Complete blood count (CBC) must meet the following criteria (no blood transfusions or blood products within 14 days, and no use of G-CSF or other hematopoietic growth factors for correction):
       A. Hemoglobin (Hb) >= 90 g/L;
       B. Absolute neutrophil count (ANC) >= 1.5 × 10⁹/L;
       C. Platelet count (PLT) >= 100 × 10⁹/L;
(2) Biochemical tests must meet the following criteria:
       A. Total bilirubin (TBIL) < 1.5 times the upper limit of normal (ULN);
       B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times ULN; for patients with liver metastases, < 5 times ULN;
       C. Serum creatinine (Cr) <= 1.5 ULN or estimated glomerular filtration rate (eGFR) > 60 mL/min (Cockcroft-Gault formula);
       D. Urinalysis results showing urine protein (UPRO) < 2+ or 24-hour urine protein quantification < 1 g;
(3) Doppler echocardiography assessment: Left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%);
(4) Coagulation function: International Normalized Ratio (INR) <= 1.5×ULN and activated partial thromboplastin time (aPTT) <= 1.5×ULN;
12. Women of childbearing potential must agree to use effective contraception during the study and for 6 months after its completion; they must have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must not be breastfeeding; men must agree to use contraception during the study and for 6 months after its completion;

排除标准：

1、对治疗药物过敏者； 2、因肠癌肝转移已经接受过标准治疗的患者； 3、既往因任何恶性肿瘤接受过抗肿瘤治疗或放射疗法； 4、同时在其他临床试验中接受抗肿瘤疗法，包括内分泌疗法、双磷酸盐类疗法或免疫疗法； 5、在入组前4周内接受过重大与结直肠癌无关的手术操作，或患者尚未从此类手术操作中完全恢复； 6、肝外转移、不可切除的淋巴结（包括门静脉淋巴结）转移和原发性肿瘤复发患者； 7、影像学显示肿瘤已侵犯重要血管或经研究者判断在后续研究期间肿瘤极有可能侵袭重要血管而引起致命大出血的患者； 8、5年内受试者既往或同时患有其它恶性肿瘤需要积极治疗(已充分治疗的如预计5年生存期>90%基底细胞或鳞状上皮细胞皮肤癌、宫颈原位癌、原位乳腺癌除外)； 9、存在活动性自身免疫病或免疫缺陷，或具有下述病史，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）。 10、HIV检测阳性或患有其它获得性、先天性免疫缺陷疾病，或有器官移植史者、异体造血干细胞移植史者。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、患者正在使用免疫抑制剂、或全身激素治疗以达到免疫抑制目的（剂量>10mg/天泼尼松或其他等疗效激素），并在入组前2周内仍在继续使用的； 12、既往2周内使用过大剂量抗生素全身性治疗的患者； 13、首次给药前6个月内发生过动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作、脑出血、脑栓塞等）、深静脉血栓及肺栓塞者； 14、有显著临床意义的心血管疾病，包括但不限于入组前 6 个月内急性心肌梗死、严重/不稳定心绞痛或者冠脉搭桥术；充血性心力衰竭纽约心脏协会（NYHA）分级≥ 2 级；需要药物治疗的室性心律失常（包括QTc间期男性≥ 450 ms、女性≥ 470 ms）；左心室射血分数（LVEF）<50%； 15、活动性或未能控制的严重感染(≥CTCAE5.0 2级感染)，包括但不限于因感染并发症、菌血症或严重肺炎住院，首次给药前发生原因不明发热>38.5℃； 16、伴有临床症状的且经研究者判断需要频繁进行引流的胸腔积液、心包积液或腹水； 17、肝硬化、活动性肝炎；乙肝参考：HBsAg阳性，且HBV DNA超过正常值上限（1000拷贝数/ml或500 IU/ml）；既往有乙型肝炎病毒(HBV) 感染或已治愈HBV感染的患者(定义为乙肝核心抗体[HBcAb]存在和HBsAg不存在,并在筛选期检测HBV DNA值正常者可纳入；丙肝参考：HCV抗体阳性，且HCV病毒滴度检测值超过正常值上限/HCV RNA或HCV Ab检测提示急慢性感染； 18、尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者； 19、具有精神类药物滥用史且无法戒除或有精神障碍者； 20、肺纤维化、尘肺、放射性肺炎、药物性肺炎和严重肺功能损害的患者； 21、妊娠（用药前妊娠检测阳性）或正在哺乳的女性； 22、入选本研究前 28 天内实施过外科手术（活检术除外）或者手术切口没有完全愈合； 23、首次给药前4周内接种过或计划接种减毒活疫苗； 24、签署知情同意书前4周内曾接受其他任何试验药物治疗或参加其他干预性研究； 25、根据研究者的判断，认为不适合入组的患者；

Exclusion criteria：

1. Patients with allergies to the study drug; 2. Patients who have already received standard treatment for liver metastases from colorectal cancer; 3. Patients with a history of anticancer therapy or radiation therapy for any malignancy; 4. Patients currently receiving anticancer therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy; 5. Patients who have undergone major surgery unrelated to colorectal cancer within 4 weeks prior to enrollment, or who have not yet fully recovered from such surgery; 6. Patients with extrahepatic metastases, unresectable lymph node metastases (including portal vein lymph nodes), or recurrence of the primary tumor; 7. Patients in whom imaging shows tumor invasion of major blood vessels, or who, in the investigator’s judgment, are highly likely to develop tumor invasion of major blood vessels during the study, potentially leading to life-threatening hemorrhage; 8. Patients with a history of, or concurrent, other malignancies requiring active treatment within the past 5 years (excluding adequately treated conditions such as basal cell or squamous cell skin cancer with an estimated 5-year survival rate >90%, cervical carcinoma in situ, or breast carcinoma in situ); 9. Patients with active autoimmune diseases or immunodeficiency, or with a history of the following conditions, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc.; 10. HIV-positive status, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation or allogeneic hematopoietic stem cell transplantation. Exceptions: Patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be enrolled in the study. Patients with type 1 diabetes whose blood glucose is controlled through an insulin regimen may participate in this study. 11. Patients currently receiving immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose > 10 mg/day of prednisone or other corticosteroids of equivalent potency) and who continue to use these medications within 2 weeks prior to enrollment; 12. Patients who have received high-dose systemic antibiotic therapy within the past 2 weeks; 13. Patients who have experienced an arterial or venous thromboembolic event within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, or pulmonary embolism; 14. Patients with clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Class >= 2 congestive heart failure; ventricular arrhythmias requiring medication (including QTc interval >= 450 ms in males and >= 470 ms in females); left ventricular ejection fraction (LVEF) < 50%; 15. Active or uncontrolled severe infection (>= CTCAE 5.0 Grade 2 infection), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia; unexplained fever > 38.5°C occurring prior to the first dose; 16. Pleural effusion, pericardial effusion, or ascites with clinical symptoms and requiring frequent drainage as determined by the investigator; 17. Cirrhosis, active hepatitis; Hepatitis B: HBsAg-positive and HBV DNA exceeding the upper limit of normal (1,000 copies/mL or 500 IU/mL) ; Patients with a history of hepatitis B virus (HBV) infection or cured HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg, and normal HBV DNA levels during the screening period may be included); Hepatitis C reference: HCV antibody positive, and HCV viral titer exceeding the upper limit of normal / HCV RNA or HCV Ab testing indicating acute or chronic infection; 18. Patients with a urine routine test indicating proteinuria >=++ and confirmed 24-hour urine protein quantification > 1.0 g; 19. Patients with a history of psychotropic drug abuse who are unable to abstain or who have a psychiatric disorder; 20. Patients with pulmonary fibrosis, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, or severe pulmonary dysfunction; 21. Pregnant women (positive pregnancy test prior to drug administration) or women who are currently breastfeeding; 22. Patients who have undergone surgery (excluding biopsy) within 28 days prior to enrollment in this study, or whose surgical incisions have not fully healed; 23. Patients who have received or plan to receive a live attenuated vaccine within 4 weeks prior to the first dose; 24. Received treatment with any other investigational drug or participated in any other interventional study within 4 weeks prior to signing the informed consent form; 25. Patients whom the investigator deems unsuitable for enrollment;

研究实施时间：

Study execute time：

从 From 2026-04-15 00:00:00至 To 2028-10-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-15 00:00:00 至 To 2028-10-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	37
Group：	Experimental group	Sample size：	37
干预措施：	阿得贝利单抗+贝伐珠单抗(RAS或BRAF突变型)/西妥昔单抗(RAS/BRAF野生型)+5FU/LV ±奥沙利铂 ±伊立替康	干预措施代码：
Intervention：	Adebelizumab + bevacizumab (RAS- or BRAF-mutant) / cetuximab (RAS/BRAF wild-type) + 5-FU/LV ± oxaliplatin ± irinotecan	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

测量指标：

Outcomes：

指标中文名：	3个月的转化率	指标类型：	主要指标
Outcome：	3-month conversion 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：	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：	药物治疗安全性	指标类型：	次要指标
Outcome：	Safety of Drug Therapy	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：	R0切除率	指标类型：	次要指标
Outcome：	R0 resection 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：	无事件生存期	指标类型：	次要指标
Outcome：	Event-free 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：	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：

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:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	是Yes
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）：	文章发表后，请邮件咨询
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After the article is published, please contact us by email.
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：	CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-04-14 17:55:36