ChiCTR2600126499 版本V1.0 版本创建时间2026/06/10 09:21:22 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600126499 

最近更新日期：

Date of Last Refreshed on：

 2026-06-10 09:21:00 

注册时间：

Date of Registration：

 2026-06-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

伊立替康/伊立替康脂质体（II）联合奥沙利铂、贝伐珠单抗用于标准二线治疗失败的晚期结直肠癌患者的双队列、单中心、开放标签临床研究

Public title：

A double-cohort, single-center, open-label clinical study of irinotecan/irinotecan liposomes (II) combined with oxaliplatin and bevacizumab in patients with advanced colorectal cancer who have failed standard second-line treatment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

伊立替康/伊立替康脂质体（II）联合奥沙利铂、贝伐珠单抗用于标准二线治疗失败的晚期结直肠癌患者的双队列、单中心、开放标签临床研究

Scientific title：

A double-cohort, single-center, open-label clinical study of irinotecan/irinotecan liposomes (II) combined with oxaliplatin and bevacizumab in patients with advanced colorectal cancer who have failed standard second-line treatment

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：

陈敬德 

研究负责人：

陈敬德 

Applicant：

Jingde Chen 

Study leader：

Jingde Chen 

申请注册联系人电话：

Applicant telephone：

 +86 21 3880 4518

研究负责人电话：

Study leader's
telephone：

+86 21 3880 4518

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：

 nade@163.com

研究负责人电子邮件：

Study leader's E-mail：

 nade@163.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：

上海市浦东新区云台路1800号

研究负责人通讯地址：

上海市浦东新区云台路1800号

Applicant address：

No. 1800, Yuntai Road, Pudong New District, Shanghai, China

Study leader's address：

No. 1800, Yuntai Road, Pudong New District, Shanghai, 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：

上海市东方医院

Applicant's institution：

Shanghai East Hospital

研究负责人所在单位：

上海市东方医院

Affiliation of the Leader：

Shanghai East 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：

 [2026]研审第(106)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：

上海市东方医院（同济大学附属东方医院）医学伦理委员会

Name of the ethic committee：

Tongji University School of Medicine,Shanghai East Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-23 00:00:00

伦理委员会联系人：

徐增光

Contact Name of the ethic committee：

Xu Zengguang

伦理委员会联系地址：

上海市浦东新区云台路1800号

Contact Address of the ethic committee：

1800 Yuntai Road, Pudong New Area, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 3880 4518

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：

上海市东方医院

Primary sponsor：

Shanghai East Hospital

研究实施负责（组长）单位地址：

上海市浦东新区云台路1800号

Primary sponsor's address：

No. 1800, Yuntai Road, Pudong New District, Shanghai, 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)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市东方医院

具体地址：

上海市浦东新区云台路1800号

Institution
hospital：

Shanghai East Hospital

Address：

1800 Yuntai Road, Pudong New District, Shanghai

经费或物资来源：

江苏恒瑞医药股份有限公司

Source(s) of funding：

Jiangsu Hengrui Pharmaceutical Co., Ltd

研究疾病：

晚期结直肠癌  

Target disease：

Advanced 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：

评估伊立替康/伊立替康脂质体（II）联合奥沙利铂、贝伐珠单抗用于标准二线治疗失败的晚期结直肠癌患者的疗效及安全性。  

Objectives of Study：

Evaluate the efficacy and safety of irinotecan/irinotecan liposomes (II) combined with oxaliplatin and bevacizumab in patients with advanced colorectal cancer who have failed standard second-line treatment.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.18-75岁，性别不限； 2.经病理学/细胞学确诊的结直肠腺癌（所有其他组织学类型都排除在外）患者； 3.既往曾接受过至少两线标准治疗（包括含奥沙利铂/伊立替康的方案，但使用过奥沙利铂和伊立替康联合方案的除外），有影像学证据证明疾病进展； 4.根据 RECIST 1.1 标准，患者至少具有一个可测量的靶病灶； 5.ECOG评分：0~1 分； 6.预计生存期 ≥3 个月； 7.主要器官功能良好，即随机前14天内相关检查指标满足以下要求： （1）血常规检查（筛选前14天内未输血，未用过升白、升血小板药物）：血红蛋白 > 90 g/L；中性粒细胞计数> 1.5×10^9/L；血小板计数> 75×10^9/L； （2）生化检查：总胆红素 ≤ 1.5×ULN（正常值上限）；血谷丙转氨酶（ALT）和血谷草转氨酶（AST）≤ 2.5×ULN；如有肝转移，则ALT和AST ≤ 5×ULN；血清肌酐[Cr]≤1×ULN （Cockcroft-Gault公式）；（3）心脏多普勒超声评估：左室射血分数 (LVEF，Left ventricular ejection fraction) ≥ 50%。 8.受试者接受其它治疗造成的损害已恢复； 9.受试者自愿加入本研究，签署知情同意书，依从性好，配合随访。

Inclusion criteria

1. Aged 18-75, of either gender; 2. Patients with colorectal adenocarcinoma confirmed by pathology/cytology (all other histological types are excluded); 3. Have previously received at least two lines of standard treatment (including regimens containing oxaliplatin/irinotecan, except for those who have used a combination regimen of oxaliplatin and irinotecan), with radiographic evidence of disease progression; 4. According to the RECIST 1.1 criteria, the patient must have at least one measurable target lesion; 5. ECOG score: 0-1 points; 6. Expected survival duration >=3 months; 7. The main organs function well, meaning that the relevant examination indicators within 14 days before randomization meet the following requirements: (1) Blood routine examination (no blood transfusion or use of leukocyte-increasing or platelet-increasing drugs within 14 days before screening): Hemoglobin > 90 g/L; Neutrophil count > 1.5×10^9/L; Platelet count > 75×10^9/L; (2) Biochemical examination: Total bilirubin <= 1.5×ULN (upper limit of normal); serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5×ULN; in case of liver metastasis, ALT and AST <= 5×ULN; serum creatinine [Cr] <= 1×ULN (Cockcroft-Gault formula); (3) Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >= 50%. 8. The damage caused by the subject's receiving other treatments has been restored; 9. The subjects voluntarily joined this study, signed the informed consent form, exhibited good compliance, and cooperated with follow-up visits.

排除标准：

1.既往5年内曾患其他恶性肿瘤的患者（治愈的原位癌、皮肤基底细胞癌除外）； 2.已知对研究药物及相关成分等过敏； 3.入组前四周内参加过其他药物临床试验； 4.存在任何影像学证实的骨转移病灶者； 5.筛选前 6 个月内活动性胃/十二指肠溃疡或溃疡性结肠炎病史、未切除的胃肠道肿瘤活动性出血、穿孔或瘘管病史；或研究者判断可能导致胃肠道出血或穿孔的任何其他情况； 6.存在肠道梗阻或存在肠道梗阻的症状和体征，或既往接受过肠道支架植入术且至筛选期肠道支架仍未取出; 7.严重腹泻（根据NCI-CTCAE6.0标准，二级及以上的腹泻：与基线相比，大便次数增加每天>=4次；造瘘口排出物中重度增加；日常生活活动受限） 8.已知的周围神经病变（CTCAE≥3级）； 9.有出血病史，筛选前4周内发生任何严重分级达到 CTCAE 6.0 3 级或以上的出血事件； 10.筛选前已知有中枢神经系统转移或有中枢神经系统转移病史的患者，但无临床症状的患者除外。对于临床疑似中枢神经系统转移的患者，随机化前28天内必须进行增强CT或增强核磁共振（MRI）检查，排除中枢神经系统转移； 11.患有高血压且经单一降压药物治疗无法获得良好控制者（收缩压 > 140 mmHg，舒张压 > 90 mmHg）；具有不稳定型心绞痛病史者；筛选前3个月内新诊断为心绞痛者或筛选前6个月内发生心肌梗塞事件；心律失常（包括QTcF：男性≥450 ms，女性≥470 ms）需长期使用抗心律失常药物及纽约心脏病协会分级≥II级心功能不全； 12.尿常规提示尿蛋白≥++且证实24小时尿蛋白定量>1.0 g； 13.长期未愈合的伤口或愈合不全的骨折； 14.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； 15.凝血功能异常，具有出血倾向者（入组前14天必须满足：在不使用抗凝剂的情况下INR在正常值范围内）；应用抗凝剂或维生素K 拮抗剂如华法林、肝素或其类似物治疗的患者；在凝血酶原时间国际标准化比值（INR，International Normalized Ratio）≤ 1.5的前提下，允许以预防目的使用小剂量华法林（1 mg口服，每日一次）或小剂量阿司匹林（每日用量不超过100 mg）； 16.存在活动性乙肝（HBV DNA ≥ 200 IU/mL或1000 copies/mL或≥其正常值上限），丙型肝炎（丙肝抗体阳性，且HCV RNA高于分析方法检测下限）； 17.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； 18.对于女性受试者：非手术绝育或非绝经后的患者拒绝在研究治疗期间和研究治疗期结束后6个月内采用一种经医学认可的避孕措施；育龄女性在研究入组前的7天内血清或尿妊娠试验为阳性，或正处于哺乳期。男性受试者：非手术绝育且拒绝在研究治疗期间和研究治疗期结束后6个月内采用一种经医学认可的避孕措施的患者； 19.存在活动性自身免疫病或有自身免疫病病史且可能复发； 其他经治研究者判断不适合纳入的患者。

Exclusion criteria：

1. Patients who have suffered from other malignant tumors within the past 5 years (excluding cured carcinoma in situ and cutaneous basal cell carcinoma); 2. Known allergy to the study drug and related components; 3. Participated in other drug clinical trials within four weeks before enrollment; 4. Patients with any imaging-confirmed bone metastatic lesions; 5. History of active gastric/duodenal ulcer or ulcerative colitis within the previous 6 months; active bleeding, perforation, or fistula of unresected gastrointestinal tumors; or any other condition that, in the investigator's judgment, may lead to gastrointestinal bleeding or perforation; 6. Presence of intestinal obstruction or symptoms and signs of intestinal obstruction, or previous intestinal stent implantation and the intestinal stent remains unremoved up to the screening period; 7. Severe diarrhea (according to the NCI-CTCAE 6.0 criteria, Grade 2 or higher diarrhea: an increase in stool frequency of >=4 times per day compared to baseline; moderate to severe increase in stoma discharge; limitation in activities of daily living) 8. Known peripheral neuropathy (CTCAE >= Grade 3); 9. History of bleeding, with any severe bleeding event reaching CTCAE 6.0 Grade 3 or above occurring within 4 weeks prior to screening; 10. Patients with known or history of central nervous system metastasis before screening, except for those without clinical symptoms. For patients clinically suspected of having central nervous system metastasis, an enhanced CT or enhanced magnetic resonance imaging (MRI) examination must be performed within 28 days before randomization to exclude central nervous system metastasis; 11. Patients with hypertension who cannot achieve good control with single antihypertensive drug therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); patients with a history of unstable angina pectoris; patients newly diagnosed with angina pectoris within 3 months before screening or who have experienced myocardial infarction within 6 months before screening; patients with arrhythmias (including QTcF: >=450 ms for males and >=470 ms for females) requiring long-term use of antiarrhythmic drugs and New York Heart Association functional classification of >=II heart dysfunction; 12. Urine routine test indicates urinary protein >=++ and confirmed 24-hour urinary protein quantitation >1.0 g; 13. Long-term unhealed wounds or incomplete healing of fractures; 14. Imaging studies show that the tumor has invaded the surrounding area of important blood vessels, or the researcher judges that there is a high possibility that the patient's tumor will invade important blood vessels during treatment, potentially causing fatal massive hemorrhage; 15. Patients with abnormal coagulation function and a tendency to bleed (must meet the following criteria 14 days before enrollment: INR within the normal range without the use of anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogs; patients are allowed to use low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for preventive purposes, provided that the International Normalized Ratio (INR) of prothrombin time is <= 1.5; 16. Presence of active hepatitis B (HBV DNA >= 200 IU/mL or 1000 copies/mL or >= upper limit of normal), hepatitis C (positive for hepatitis C antibody, and HCV RNA above the detection limit of the analytical method); 17. Screen for individuals who have experienced arterial or venous thromboembolic events within the previous year, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (excluding those who have been judged by the researcher to have fully recovered from venous thrombosis caused by venous catheterization during previous chemotherapy), and pulmonary embolism; 18. For female subjects: patients who have not undergone surgical sterilization or are not postmenopausal and refuse to adopt a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period; female subjects of childbearing age who have a positive serum or urine pregnancy test within 7 days before study enrollment, or are currently breastfeeding. For male subjects: patients who have not undergone surgical sterilization and refuse to adopt a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period; 19. Having active autoimmune disease or a history of autoimmune disease with potential for recurrence; Other patients who are deemed unsuitable for inclusion by the treating researchers.

研究实施时间：

Study execute time：

从 From 2026-02-01 00:00:00至 To 2028-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-07-01 00:00:00 至 To 2027-02-28 00:00:00

干预措施：

Interventions：

组别：

试验组1

样本量：

 27

Group：

Experimental Group 1

Sample size：

干预措施：

贝伐珠单抗：5 mg/kg，静脉输注，d1 伊立替康：150-180mg/m^2，静脉输注，d1 奥沙利铂：85mg/m^2，IV，d1，静脉输注 2-6h

干预措施代码：

Intervention：

Bevacizumab: 5 mg/kg, intravenous infusion, d1 Irinotecan: 150-180mg/m^2, intravenous infusion, day 1 Oxaliplatin: 85mg/m^2, IV, d1, intravenous infusion for 2-6 hours

Intervention code：

组别：

试验组2

样本量：

 27

Group：

Experimental Group 2

Sample size：

干预措施：

贝伐珠单抗：5 mg/kg，静脉输注，d1 伊立替康脂质体（II）：60mg/m^2(按游离碱计)，静脉输注至少 90 min，d1 奥沙利铂：85mg/m^2，IV，d1，静脉输注 2-6h

干预措施代码：

Intervention：

Bevacizumab: 5 mg/kg, intravenous infusion, d1 Irinotecan liposomes (II): 60mg/m^2 (calculated as free base), intravenous infusion for at least 90 minutes, d1 Oxaliplatin: 85mg/m^2, IV, d1, intravenous infusion for 2-6 hours

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海市东方医院 

单位级别：

 三甲 

Institution
hospital：

Shanghai East 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, PFS

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, 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：

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：

不良事件

指标类型：

次要指标

Outcome：

Adverse Event, AE

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

缓解持续时间（DoR）

指标类型：

次要指标

Outcome：

Duration of response (DoR)

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）：

不随机分组

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

non-randomization

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）：

Calculated Results after
the Study Completed(upload file)：

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：

病例报告表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form, 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：

  2026-06-10 09:21:00