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：	ChiCTR2500110035
最近更新日期： Date of Last Refreshed on：	2025-09-29 09:58:40
注册时间： Date of Registration：	2025-09-29 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	基于伊立替康脂质体的XELIRI方案联合贝伐珠单抗治疗转移性结直肠癌患者的有效性和安全性临床研究
Public title：	Clinical study on the efficacy and safety of XELIRI regimen based on irinotecan liposome combined with bevacizumab in the treatment of patients with metastatic colorectal cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于伊立替康脂质体的XELIRI方案联合贝伐珠单抗治疗转移性结直肠癌患者的有效性和安全性临床研究
Scientific title：	Clinical study on the efficacy and safety of XELIRI regimen based on irinotecan liposome combined with bevacizumab in the treatment of patients with metastatic colorectal 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：	刘璇	研究负责人：	徐靖
Applicant：	Liu Xuan	Study leader：	Xu Jing
申请注册联系人电话： Applicant telephone：	+86 177 7543 6805	研究负责人电话： Study leader's telephone：	+86 138 0206 5919
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：	lx19980619@163.com	研究负责人电子邮件： Study leader's E-mail：	xujingdoc@126.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：	天津市河西区气象台路124号蓝帆大厦	研究负责人通讯地址：	天津市红桥区芥园道190号
Applicant address：	Lanfan Building, No. 124, Meteorological Road, Hesihedao District, Tianjin	Study leader's address：	No. 190, Jieyuan Road, Hongqiao District, Tianjin
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：	江苏恒瑞医药股份有限公司
Applicant's institution：	Jiangsu Hengrui Medicine Co., Ltd.
研究负责人所在单位：	天津市人民医院
Affiliation of the Leader：	Tianjin People's Hospital

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：	(2024)年快审第(C09)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：	天津市人民医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Tianjin People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-05-08 00:00:00
伦理委员会联系人：	宋老师
Contact Name of the ethic committee：	Teacher Song
伦理委员会联系地址：	天津市红桥区芥园道190号
Contact Address of the ethic committee：	No. 190, Jieyuan Road, Hongqiao District, Tianjin
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 22 2755 7411	伦理委员会联系人邮箱： Contact email of the ethic committee：	lunli7411@163.com

研究实施负责（组长）单位：

天津市人民医院

Primary sponsor：

Tianjin People's Hospital

研究实施负责（组长）单位地址：

天津市红桥区芥园道190号

Primary sponsor's address：

No. 190, Jieyuan Road, Hongqiao District, Tianjin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	天津	市(区县)：
Country：	China	Province：	Tianjin	City：
单位(医院)：	天津市人民医院	具体地址：	天津市红桥区芥园道190号
Institution hospital：	Tianjin People's Hospital	Address：	No. 190, Jieyuan Road, Hongqiao District, Tianjin

经费或物资来源：

企业合作资助

Source(s) of funding：

Enterprise cooperation funding

研究疾病：

转移性结直肠癌

Target disease：

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：

单臂

Study design：

Single arm

研究目的：

本研究采用基于伊立替康脂质体的XELIRI方案联合贝伐珠单抗治疗转移性结直肠癌患者，评估其安全性和有效性

Objectives of Study：

This study employed the XELIRI regimen based on irinotecan liposomes in combination with bevacizumab to treat patients with metastatic colorectal cancer, aiming to evaluate its safety and efficacy.

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. Histologically confirmed unresectable colorectal adenocarcinoma, excluding goblet cell carcinoid of the appendix and anal canal cancer;
2. Male or female, aged >=18 and <=70 years at the time of signing the ICF;
3. ECOG performance status 0-2;
4. Disease progression or intolerable toxicity following first-line oxaliplatin-based chemotherapy (with or without molecular targeted therapy);
5. At least one measurable lesion according to RECIST 1.1 criteria for solid tumor response evaluation;
6. Expected survival of >=12 weeks;
7. Normal major organ and bone marrow function, meeting the following requirements:   
(1) Hematologic function: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count >= 75 x 10^9/L;   
(2) Adequate renal function: serum creatinine <1.5 x ULN or creatinine clearance >40 mL/min (Cockcroft-Gault formula);   
(3) Hepatic function: total bilirubin <= 1.5 x ULN, AST and ALT <= 2.5 x ULN; if liver metastases are present, ALT and AST <= 5 x ULN;   
(4) Coagulation function: for patients not receiving anticoagulant therapy, prothrombin time international normalized ratio (INR) <=1.5, activated partial thromboplastin time (APTT) <=1.5 x ULN;   
(5) Left ventricular ejection fraction (LVEF) >=50%; QTc <450ms for males, <470ms for females;
8. Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and use effective contraception during the study and for at least 3 months after the last dose (e.g., IUD, contraceptive pills, or condoms); male participants with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose;
9. Participants voluntarily join this study and sign the informed consent form.

排除标准：

1.既往接受过伊立替康治疗； 2.存在有临床症状、无法通过引流或其他方法控制的第三间隙积液（如大量胸水或腹水）； 3.患有任何活动性自身免疫疾病或自身免疫疾病史（如间质性肺炎、葡萄膜炎、肠炎、肝炎、垂体炎、血管炎、心肌炎、肾炎、甲状腺功能亢进、甲状腺功能降低（激素替代治疗后可纳入））；患有童年期哮喘已完全缓解且成人后无需任何干预或白癜风可纳入，需要支气管扩张剂进行医学干预的患者则不可纳入； 4.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，活动性乙型肝炎（HBV DNA ≥ 500 IU/ml），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； 5.首次用药前2周内并发重度感染（如：需要静脉滴注抗生素、抗真菌或抗病毒药物） 6.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； 7.最近5年内患过或伴有其它系统恶性肿瘤，已治愈的皮肤基底细胞癌和宫颈原位癌及卵巢癌除外； 8.已知对任何试验药物过敏者； 9.妊娠、哺乳期患者，有生殖能力的患者不愿意采取有效的避孕措施； 10.既往有明确的神经或精神障碍史，包括癫痫和痴呆; 11.已知无法控制的或有症状的活动性中枢神经系统（CNS）转移，表现为出现临床症状、脑水肿、脊髓压迫、癌性脑膜炎、软脑膜疾病和/或进展性生长； 12.无法吞咽研究药物的患者，如存在慢性腹泻（包括但不限于肠易激综合症， Crohn's 病，溃疡性结肠炎）和肠梗阻等影响药物服用和吸收的多种因素； 13.研究者认为不适合纳入的其他情况。如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。

Exclusion criteria：

1. Has received irinotecan treatment before; 2. Has clinical symptoms that cannot be controlled by drainage or other methods and involve third-space effusion (such as large amounts of pleural effusion or ascites); 3. Has any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (including hormone replacement therapy), and vitiligo); has completely resolved childhood asthma and no intervention is needed after adulthood or vitiligo can be included; patients requiring bronchodilators for medical intervention are not included; 4. Has congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit of the analytical method) or co-infection of hepatitis B and hepatitis C; 5. Had severe infection within 2 weeks before the first medication (such as: requiring intravenous infusion of antibiotics, antifungal or antiviral drugs); 6. Had thromboembolic events in the arteries or veins within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 7. Had other systemic malignant tumors within the last 5 years, except for cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer; 8. Has known allergies to any trial drugs; 9. Pregnant or lactating patients, patients with reproductive ability who are unwilling to take effective contraceptive measures; 10. Has a clear history of neurological or mental disorders, including epilepsy and dementia; 11. Has uncontrollable or symptomatic active central nervous system (CNS) metastasis, manifested as clinical symptoms, brain edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease and/or progressive growth; 12. Patients unable to swallow the study drug, such as those with chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction that affect the administration and absorption of the drug; 13. Other conditions that the investigator considers not suitable for inclusion, such as those affected by family or social factors that may endanger the safety of the subjects or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2026-08-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-05-10 00:00:00 至 To 2025-08-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	30
Group：	Experimental group	Sample size：	30
干预措施：	伊立替康脂质体60mg/m^2，静脉输注90min（±30min），第1天，Q3W; 卡培他滨，每次800mg/m^2，口服，每日2次，1~14天，Q3W; 贝伐珠单抗7.5mg/kg，静脉输注，第1天, Q3W; 当患者UGT1A1*28等位基因为纯合子，伊立替康脂质体剂量调整为50mg/m^2	干预措施代码：
Intervention：	Irinotecan liposome 60 mg/m^2, intravenous infusion over 90 minutes (±30 minutes) on Day 1, every 3 weeks (Q3W); Capecitabine 800 mg/m^2 per dose, orally, twice daily, Days 1–14, every 3 weeks (Q3W); Bevacizumab 7.5 mg/kg, intravenous infusion on Day 1, every 3 weeks (Q3W); If the patient has a homozygous UGT1A1*28 allele, the dose of irinotecan liposome should be adjusted to 50 mg/m^2	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	天津	市(区县)：
Country：	China	Province：	Tianjin	City：
单位(医院)：	天津市人民医院	单位级别：	三甲
Institution hospital：	Tianjin People's Hospital	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 period	Type：	Primary 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, OS	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	治疗失败时间	指标类型：	次要指标
Outcome：	Time to Treatment Failure, TTF	Type：	Secondary 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, ORR	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, DCR	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：

结束

/Completed

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)：

No

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	邮箱联系研究者
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Contact the researcher 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：	CRF
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：	暂未确定/Not yet
注册人： Name of Registration：	2025-09-29 09:58:29