ChiCTR2600126181 版本V1.0 版本创建时间2026/06/04 16:48:11 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：

 ChiCTR2600126181 

最近更新日期：

Date of Last Refreshed on：

 2026-06-04 16:47:51 

注册时间：

Date of Registration：

 2026-06-04 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）联合卡瑞利珠单抗、氟尿嘧啶类药物用于既往一线标准治疗失败的转移性食管鳞癌：一项前瞻性、单臂、探索性临床研究

Public title：

Irinotecan Liposome (II) Combined with Camrelizumab and Fluorouracil Drugs for Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Standard Therapy: A Prospective, Single-Arm, Exploratory Clinical Study

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）联合卡瑞利珠单抗、氟尿嘧啶类药物用于既往一线标准治疗失败的转移性食管鳞癌：一项前瞻性、单臂、探索性临床研究

Scientific title：

Irinotecan Liposome (II) Combined with Camrelizumab and Fluorouracil Drugs for Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Standard Therapy: A Prospective, Single-Arm, 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：

陈勇 

研究负责人：

陈勇 

Applicant：

Chen Yong 

Study leader：

Chen Yong 

申请注册联系人电话：

Applicant telephone：

 +86 180 5106 2926

研究负责人电话：

Study leader's
telephone：

+86 180 5106 2926

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：

 29008315@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 29008315@qq.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：

江苏省扬州市泰州路45号

研究负责人通讯地址：

江苏省扬州市泰州路45号

Applicant address：

No. 45 Taizhou Road, Yangzhou City, Jiangsu Province, China

Study leader's address：

No. 45 Taizhou Road, Yangzhou City, Jiangsu Province, 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：

扬州大学附属医院

Applicant's institution：

Affiliated Hospital Of Yangzhou Univrtsity

研究负责人所在单位：

扬州大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Yangzhou Univrtsity

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-YKL05-K12

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：

扬州大学附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Yangzhou University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-14 00:00:00

伦理委员会联系人：

许冰菊

Contact Name of the ethic committee：

Xu Bingju

伦理委员会联系地址：

扬州大学附属医院西区医院行政楼506室

Contact Address of the ethic committee：

Room 506, Administration Building, West Campus Hospital, Affiliated Hospital of Yangzhou University.

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 514 8031 9670

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：

扬州大学附属医院

Primary sponsor：

Affiliated Hospital of Yangzhou Univrtsity

研究实施负责（组长）单位地址：

江苏省扬州市邗江区邗江中路368号

Primary sponsor's address：

No. 368 Hanjiang Middle Road, Hanjiang District, Yangzhou, 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)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

扬州大学附属医院

具体地址：

江苏省扬州市邗江区邗江中路368号

Institution
hospital：

Affiliated Hospital of Yangzhou Univrtsity

Address：

No. 368 Hanjiang Middle Road, Hanjiang District, Yangzhou, Jiangsu Province

经费或物资来源：

自筹

Source(s) of funding：

Self-financing

研究疾病：

食管癌  

Target disease：

Esophageal 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：

评价伊立替康脂质体（II）联合卡瑞利珠单抗、氟尿嘧啶类药物用于既往一线标准治疗失败的转移性食管鳞癌的有效性与安全性  

Objectives of Study：

To evaluate the efficacy and safety of irinotecan liposomal (II) in combination with camrelizumab and fluorouracil in metastatic esophageal squamous cell carcinoma who have failed previous first-line standard therapy

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（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局部晚期、局部复发或转移食管鳞状细胞癌； 3.既往接受过食管鳞状细胞癌的一线标准治疗且治疗失败或不耐受： a)治疗失败或不耐受指：①治疗过程中或末次治疗后疾病进展，须有明确影像学或临床进展证据；②因无法耐受不良事件而退出标准治疗的患者，按CTCAE 5.0标准，其不耐受的不良事件指≥ Ⅳ级的血液学毒性或≥ Ⅲ级的非血液学毒性或≥ Ⅱ级的心、肝、肾等主要脏器的损害； b)以下治疗方法不计入接受一线标准治疗：①新辅助治疗阶段采用的治疗；②辅助治疗完成后超过6个月复发（若辅助治疗期间或完成治疗后6个月内复发，则计入）； 4.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）； 5.预期生存时间 ≥ 3个月； 6.美国东部肿瘤协作组（ECOG）体力状态评分0 ~ 1分； 7.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： a)血常规：中性粒细胞绝对计数（ANC）≥ 1.5 × 10^9/L；血小板计数（PLT）≥ 100 × 10^9/L；血红蛋白（Hb）≥ 90 g/L。筛查前14天内未输血、未使用造血刺激因子类药物纠正。 b)血生化：血清白蛋白（ALB）≥ 30 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）≤ 1.5 × 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； c)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%）； d)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）。 8.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. Age >= 18 years old (calculated based on the date of signing the informed consent form), regardless of gender; 2. Unresectable locally advanced, locally recurrent or metastatic esophageal squamous cell carcinoma diagnosed by histopathology and/or cytology; 3. Previous first-line standard treatment for esophageal squamous cell carcinoma and treatment failure or intolerance: A) Treatment failure or intolerance refers to: a. disease progression during treatment or after the last treatment, and there must be clear evidence of imaging or clinical progression; b. For patients who withdrew from standard treatment due to intolerance of adverse events, according to CTCAE 5.0 criteria, the intolerable adverse events refer to hematologic toxicity >= Grade IV or non-hematologic toxicity >= Grade III or damage to major organs such as heart, liver and kidney >= Grade II; b) The following treatment methods are not included in receiving first-line standard treatment: a. Treatment used in the neoadjuvant treatment stage; b. Recurrence more than 6 months after completion of adjuvant therapy (if recurrence occurs during adjuvant therapy or within 6 months after completion of treatment, it will be counted); 4. According to the RECIST v1.1 standard, there is at least one measurable lesion, and the measurable lesion has not received radiotherapy or other local treatment, unless it progresses after the treatment is completed (that is, the target lesion should not receive radiotherapy or other local treatment. If the lesion in the previous radiotherapy area is located, if it is confirmed to have progressed and meets the RECIST v1.1 standard, it can also be the target lesion); 5. Expected survival time >= 3 months; 6. The performance status score of the Eastern United States Cooperative Oncology Group (ECOG) is 0 ~ 1; 7. Meet the basic requirements of combination therapy, including basically normal peripheral blood picture, no obvious abnormalities in heart, liver and kidney function, and basically normal electrocardiogram, that is, the organ function level and related laboratory indicators of the subject within 14 days before the start of study treatment must meet the following requirements: A) Blood routine: absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelet count (PLT) >= 100 × 10^9/L; Hemoglobin (Hb) >= 90 g/L. Within 14 days before screening, no blood transfusion or hematopoietic stimulating factor drugs were used for correction. b) Blood biochemistry: serum albumin (ALB) >= 30 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 times the upper limit of normal (ULN) (ALT and AST <= 5 × ULN if liver metastases are present); Total bilirubin (TBIL) <= 1.5 × ULN; Serum creatinine (Cr) <= 1.5 × ULN, or endogenous creatinine clearance ≥ 60 mL/min calculated according to the Cockcroft-Gault formula; c) Cardiac function: normal 12-lead ECG or abnormal 12-lead ECG judged by the investigator as not clinically significant (i.e., QTcF < 470 ms); Left ventricular ejection fraction (LVEF) >= 50%); d) Coagulation function: prothrombin time (PT) or activated partial thromboplastin time (aPTT) <= 1.5 × ULN, international normalized ratio (INR) <= 1.5 × ULN (previous anticoagulation therapy; for use of stable doses of anticoagulation therapy such as low molecular weight heparin or warfarin and international normalized ratio [INR] within the expected therapeutic range of anticoagulants can be screened). 8. Voluntarily participate in and sign the informed consent form, and be able to comply with the study visit plan and other protocol requirements.

排除标准：

1. 肿瘤及治疗相关： 1) 在筛选前5年内曾患有食管癌以外的恶性肿瘤（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； 3) 既往接受过伊立替康/伊立替康脂质体为基础的化疗； 4) 开始研究治疗前14天内使用CYP3A4、CYP2C8和UGT1A1强抑制剂/诱导剂； 5) 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) 计划怀孕、妊娠期及哺乳期妇女； 3) 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) Had had a malignant tumor other than esophageal cancer within 5 years prior to screening (except cured skin basal cell or squamous cell carcinoma, cervical carcinoma in situ, malignant tumors with low risk of metastasis and death assessed by the investigator); 2) For patients with known central nervous system metastases, for patients with clinically suspected central nervous system metastases, enhanced computed tomography (CT) or enhanced magnetic resonance (MRI) examination must be performed within 28 days before starting study treatment to rule out central nervous system metastases; 3) Previous irinotecan/irinotecan liposome-based chemotherapy; 4) use of strong inhibitors/inducers of CYP3A4, CYP2C8, and UGT1A1 within 14 days prior to initiation of study treatment; 5) Participated in other drug clinical trials within 4 weeks before starting study treatment, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 2. Medical history or co-diseases: 1) Clinical records show severe gastrointestinal dysfunction (including bleeding, obstruction; inflammation of NCI-CTCAE v5.0 > Grade 2; diarrhea of NCI-CTCAE v5.0 > Grade 1), or other conditions that may affect the intake, transport or absorption of drugs according to the investigator's judgment (including inability to swallow; after small bowel resection or total gastrectomy, etc.); 2) pleural effusion or ascites requiring clinical intervention (NCI-CTCAE v5.0 >= Grade 2); 3) Presence of severe comorbidities that hinder treatment with the investigational drug: A) uncontrolled serious medical conditions that the investigator believes will affect the subject's ability to receive treatment under the study protocol, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, active peptic ulcer, etc.; b) Arterial/venous thrombosis events occurred within one year before screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except those who have recovered from venous thrombosis caused by venous catheterization in the early stage of chemotherapy and judged by the investigator) and pulmonary embolism, etc.; c) Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator judges that the patient's tumor has a high probability of invading important blood vessels and causing fatal bleeding during treatment; d) Previous interstitial lung disease, or (non-infectious) pneumonia requiring oral or intravenous steroid hormones; e) Clinical symptoms or diseases of the heart that are not well controlled, such as: New York Heart Association (NYHA) Grade 2 or higher heart failure; Unstable angina pectoris; Myocardial infarction within 6 months; Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; f) hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive; 4) Serious infection (NCI-CTCAE v5.0 > Grade 2) within 4 weeks before screening, such as severe pneumonia, bacteremia, infection complications requiring hospitalization, etc.; The presence of symptoms and signs of infection within 2 weeks prior to the start of study treatment required intravenous antibiotic treatment (except for prophylactic use of antibiotics). 3. Other: 1) Known allergy or intolerance to any trial drug or its excipients, or contraindications to any trial drug; 2) Planning pregnancy, pregnancy and lactating women; 3) The investigator believes that the subject should be excluded from this study, for example, according to the investigator's judgment, the subject has other factors that may lead to the forced termination of this study, such as other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, family or social factors, which will affect the safety of the subject or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2026-05-15 00:00:00至 To 2028-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-15 00:00:00 至 To 2028-03-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 34

Group：

Experimental group

Sample size：

干预措施：

伊立替康脂质体（II）+卡瑞利珠单抗+氟尿嘧啶类药物

干预措施代码：

Intervention：

Irinotecan Liposome (II) + Camrelizumab + Fluorouracil-based Drugs

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 扬州大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital Of Yangzhou Univrtsity

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

Objective response 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：

无进展生存期

指标类型：

次要指标

Outcome：

Progression-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：

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：

安全性评价

指标类型：

次要指标

Outcome：

Safety evaluation

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：

标本中文名：

尿液

组织：

Sample Name：

Urine

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 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）：

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）：

不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Do not share

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：

使用电子采集和管理系统

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

Electronic Data Capture, EDC

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：

  2026-06-04 16:47:51