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：	ChiCTR2500109401
最近更新日期： Date of Last Refreshed on：	2025-09-17 17:34:16
注册时间： Date of Registration：	2025-09-17 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）联合卡培他滨同步放化疗用于局部晚期直肠腺癌新辅助治疗的前瞻性、单臂、单中心、探索性临床研究
Public title：	Prospective, single arm, single center, exploratory clinical study of irinotecan liposomes (II) combined with capecitabine for neoadjuvant therapy in locally advanced rectal adenocarcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	伊立替康脂质体（Ⅱ）联合卡培他滨同步放化疗用于局部晚期直肠腺癌新辅助治疗的前瞻性、单臂、单中心、探索性临床研究
Scientific title：	Prospective, single arm, single center, exploratory clinical study of irinotecan liposomes (II) combined with capecitabine for neoadjuvant therapy in locally advanced rectal adenocarcinoma
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：	阎皓	研究负责人：	阎皓
Applicant：	Hao Yan	Study leader：	Hao Yan
申请注册联系人电话： Applicant telephone：	+86 132 0760 3727	研究负责人电话： Study leader's telephone：	+86 132 0760 3727
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：	sarahhao99@sina.cn	研究负责人电子邮件： Study leader's E-mail：	sarahhao99@sina.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：	天津市红桥区芥园道190号	研究负责人通讯地址：	天津市红桥区芥园道190号
Applicant address：	No. 190 Jieyuan Road, Hongqiao 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：	天津市人民医院
Applicant's institution：	Tianjin People's Hospital
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：	(2025)年快审第(C32)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：	2025-08-26 00:00:00
伦理委员会联系人：	宋磊
Contact Name of the ethic committee：	Song Lei
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：	+86 156 2050 0984	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：

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：	中国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：

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：

局部晚期直肠腺癌

Target disease：

Localized advanced rectal adenocarcinoma

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：

评估伊立替康脂质体（Ⅱ）联合卡培他滨同步放化疗用于局部晚期直肠腺癌患者新辅助治疗的疗效和安全性。

Objectives of Study：

Evaluate the efficacy and safety of irinotecan liposomes (II) combined with capecitabine for neoadjuvant therapy in locally advanced rectal adenocarcinoma patients.

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. Fully understands this study and voluntarily signs the informed consent form, complies well, and cooperates with follow-up;2. Aged >= 18 years and <= 70 years;
3. ECOG score of 0-1;
4. Expected survival time >= 12 weeks;
5. Histopathologically confirmed rectal adenocarcinoma; known to be pMMR and/or MSS;
6. Non-metastatic cancer that requires combined organ resection to achieve R0 resection, or even with combined organ resection cannot achieve R0 resection, evaluated by CT and/or MRI and a multidisciplinary team;
7. Clinical staging of T3-T4 or N;
8. The distance from the lower edge of the tumor to the anal edge is <= 10cm;
9. Patients with intestinal obstruction, after stoma surgery or stent implantation, have had relief of the obstruction;
10. Has not previously received systemic treatment, including chemotherapy, surgery, radiotherapy, targeted therapy, and immunotherapy;
11. Patients must have at least one assessable lesion (according to RECIST 1.1 criteria);
12. Main organ functions are normal, specifically meeting the following criteria: 
(1) Hematological examination standards must meet (no blood transfusions or blood products received within 14 days, no use of G-CSF or other hematopoietic growth factors): 
1) Hemoglobin (Hb) >= 90 g/L; 
2) Absolute Neutrophil Count (ANC) >= 1.5×10^9 /L; 
3) Platelet Count (PLT) >= 100×10^9 /L; 
(2) Biochemical examination must meet the following criteria: 
1) Total Bilirubin (TBIL) < 1.5 times the upper limit of normal (ULN); 
2) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 ULN; 
3) Serum Creatinine (Cr) <= 1.5 ULN or estimated creatinine clearance > 60 mL/min (using the Cockcroft-Gault formula); 
4) Urinalysis shows Urinary Protein (UPRO) < 2 or 24-hour urinary protein quantification < 1 g; 
(3) Doppler ultrasound 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 <= 1.5×ULN; 
13. Women of childbearing age must agree to use effective contraceptive measures during the study and for 6 months after the study ends; they must have a negative serum or urine pregnancy test within 7 days prior to enrollment, and must not be lactating; men must agree to use contraceptive measures during the study and for 6 months after the study ends.

排除标准：

1. 对伊立替康脂质体、其他脂质体产品、铂类药物、氟尿嘧啶类等治疗药物过敏者； 2. 入组前四周内参加过其他药物临床试验； 3. 5年内患有其它恶性肿瘤，但是已治愈的皮肤基底细胞癌和宫颈原位癌除外； 4. dMMR/MSI-H患者； 5. 已知的周围神经病变（CTCAE>=3级）； 6. 有出血病史，筛选前4周内发生任何严重分级达到CTCAE 5.0； 7. 患有FAP、HNPCC或炎症性肠病；严重的胃肠功能紊乱； 8. 入组前6个月内有胃肠道穿孔、胃肠瘘、腹腔内脓肿以及非胃肠道瘘（如气管-食管瘘）者； 9. 已知有间质性肺病，仅影像学显示的间质性改变除外； 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。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.随机前2周内伴随用药中含有CYP3A4、CYP2C8强抑制剂/强诱导剂或UGT1A1强抑制剂； 12. 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； 13. 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）； 14. 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个月内采用种经医认可的避孕措施的患者； 15. 合并活动性乙型肝炎（乙肝表面抗原阳性且HBV DNA≥ 500 IU/mL），丙型肝炎（丙肝抗体阳性，且HCV-RNA高于正常值上限）；已知有获得性免疫缺陷综合征（艾滋病）或HIV检测阳性者，活动性梅毒感染者； 16. 患者有活动性感染、随机前1周内有不明原因发热≥38.5℃、或筛选期白细胞计数>15×10^9/L；随机之前2周内口服或静脉给予治疗性抗生素（用药时间不超过48小时静脉给予的预防性抗生素除外）； 17. 既往有明确的神经或精神障碍史，包括癫痫或痴呆； 18. 根据研究者的判断，有严重的危害患者安全或影响患者完成研究的伴随疾病。

Exclusion criteria：

1. Allergies to irinotecan liposomes, other liposome products, platinum drugs, fluorouracil and other therapeutic drugs; 2. Participated in clinical trials of other drugs within the four weeks prior to enrollment; 3. Suffering from other malignant tumors within 5 years, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 4. dMMR/MSI-H patients; 5. Known peripheral neuropathy (CTCAE >= grade 3); 6. Have a history of bleeding and have experienced any severe grading of CTCAE 5.0 within the 4 weeks prior to screening; 7. Suffering from FAP, HNPCC or inflammatory bowel disease; Severe gastrointestinal dysfunction; 8. Patients with gastrointestinal perforation, gastrointestinal fistula, intra-abdominal abscess, and non gastrointestinal fistula (such as tracheoesophageal fistula) within 6 months before enrollment; 9. It is known that there is interstitial lung disease, except for interstitial changes shown only by imaging; 10. Patients known to have central nervous system metastases or a history of central nervous system metastases prior to screening. For patients suspected of having central nervous system metastases in clinical practice, prior to randomization Enhanced CT or MRI examination must be performed within 28 days to rule out central nervous system metastasis; 11. Within the first 2 weeks of randomization, concomitant medication contains strong inhibitors/inducers of CYP3A4, CYP2C8, or UGT1A1; 12. Patients with hypertension who cannot achieve good control with single antihypertensive medication (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); Individuals with a history of unstable angina pectoris; Newly diagnosed with angina pectoris within the first 3 months of screening or experiencing myocardial infarction events within the first 6 months of screening; Arrhythmia (including QTcF: >= 450 ms for males and >= 470 ms for females) requires long-term use of antiarrhythmic drugs and New York Heart Association classification of >= II heart failure; 13. Patients with abnormal coagulation function and bleeding tendency (must meet the requirement of INR being within the normal range without using anticoagulants within 14 days before enrollment); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Under the condition that the International Normalized Ratio (INR) of prothrombin time is <= 1.5, it is allowed to use low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for preventive purposes; 14. For female subjects: Non surgical sterilization or non postmenopausal patients refuse to use a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period; Women of childbearing age who tested positive for pregnancy in serum or urine within 7 days prior to enrollment in the study, or are currently breastfeeding. Male participants: patients who underwent non-surgical sterilization and refused to use a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period; 15. Complicated with active hepatitis B (hepatitis B surface antigen positive and HBV DNA >=500 IU/mL), Hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the upper limit of normal); Known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active syphilis infection; 16. The patient has an active infection, an unexplained fever of ≥ 38.5 ℃ within the first week before randomization, or a white blood cell count>15 × 10^9/L during the screening period; therapeutic antibiotics were administered orally or intravenously within the first 2 weeks before randomization (excluding prophylactic antibiotics administered intravenously for no more than 48 hours); 17. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 18. According to the researcher's judgment, there are accompanying diseases that pose a serious threat to patient safety or affect the completion of the study.

研究实施时间：

Study execute time：

从 From 2025-09-01 00:00:00至 To 2028-09-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-10-01 00:00:00 至 To 2027-09-01 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：	符合研究条件的受试者，接受长程同步放化疗，放疗总剂量为50 Gy/25次，每日1次，每周5次，连续5周完成。在放疗期间同步给予化疗药物，包括：卡培他滨：口服，剂量为625 mg/m2，bid（每日两次），给药周期为第1至第5周；伊立替康脂质体：静脉输注，剂量为40 mg/m2，于第1、3、5周分别给药一次。间隔两周后使用化疗。	干预措施代码：
Intervention：	Subjects who meet the research criteria will receive long-term synchronous radiotherapy and chemotherapy, with a total radiation dose of 50 Gy/25 times, once a day, 5 times a week, for 5 consecutive weeks. Simultaneous administration of chemotherapy drugs during radiotherapy, including: capecitabine: oral, dose of 625 mg/m 2, bid (twice daily), dosing period from week 1 to week 5; Irinotecan liposomes: intravenous infusion at a dose of 40 mg/m 2, administered once at weeks 1, 3, and 5, respectively. Chemotherapy will be administered after a two-week interval.	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：	临床获益率	指标类型：	主要指标
Outcome：	Clinical benefit 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：	3年无事件生存期（EFS）	指标类型：	次要指标
Outcome：	3-year event-free survival period (EFS)	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（OS）	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：	3年无疾病生存期（DFS）	指标类型：	次要指标
Outcome：	3-year disease-free survival (DFS)	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	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)：

none

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	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：	暂未确定/Not yet
注册人： Name of Registration：	2025-09-17 17:33:57