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：	ChiCTR2600122518
最近更新日期： Date of Last Refreshed on：	2026-04-14 17:03:12
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：	芦康沙妥珠单抗联合特瑞普利单抗治疗一线免疫治疗失败的晚期胃癌或胃食管交界处癌的单臂单中心II期临床研究
Public title：	A single-arm, single-center phase II clinical study of luconosatuzumab combined with toripalimab in the treatment of advanced gastric cancer or gastroesophageal junction cancer that failed first-line immunotherapy
注册题目简写：
English Acronym：
研究课题的正式科学名称：	芦康沙妥珠单抗联合特瑞普利单抗治疗一线免疫治疗失败的晚期胃癌或胃食管交界处癌的单臂单中心II期临床研究
Scientific title：	A single-arm, single-center phase II clinical study of luconosatuzumab combined with toripalimab in the treatment of advanced gastric cancer or gastroesophageal junction cancer that failed first-line immunotherapy
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：	陈佳艳	研究负责人：	唐曦
Applicant：	Chen Jiayan	Study leader：	Tang Xi
申请注册联系人电话： Applicant telephone：	+86 177 0186 3366	研究负责人电话： Study leader's telephone：	+86 181 2122 7790
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：	chenjiayan1986@126.com	研究负责人电子邮件： Study leader's E-mail：	olivia_tang@fudan.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：	上海市静安区延安西路221号	研究负责人通讯地址：	上海市静安区延安西路221号
Applicant address：	221 Yan'an Road West, Jing'an District, Shanghai, China	Study leader's address：	221 Yan'an Road West, Jing'an 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：	复旦大学附属华东医院
Applicant's institution：	Huadong Hospital Affiliated to Fudan University
研究负责人所在单位：	复旦大学附属华东医院
Affiliation of the Leader：	Huadong Hospital Affiliated to Fudan 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：	20260003	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：	复旦大学附属华东医院伦理委员会
Name of the ethic committee：	Ethics Committee of Huadong Hospital Affiliated to Fudan University
伦理委员会批准日期： Date of approved by ethic committee：	2026-01-05 00:00:00
伦理委员会联系人：	陈丽丽
Contact Name of the ethic committee：	Chen Lili
伦理委员会联系地址：	上海市延安西路168号309室
Contact Address of the ethic committee：	168 Yan'an Road West, Jing'an District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 181 2122 9568	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：

复旦大学附属华东医院

Primary sponsor：

Huadong Hospital Affiliated to Fudan University

研究实施负责（组长）单位地址：

上海市静安区延安西路221号

Primary sponsor's address：

221 Yan'an Road West, Jing'an 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)：	复旦大学附属华东医院	具体地址：	静安区延安西路221号
Institution hospital：	Huadong Hospital Affiliated to Fudan University	Address：	221 Yanan Road West, Jing'an District

经费或物资来源：

企业资助（四川科伦博泰有限公司）

Source(s) of funding：

Corporate sponsorship (Sichuan Kelun Botai Co., Ltd.)

研究疾病：

胃癌或胃食管交界处癌

Target disease：

Stomach cancer or cancer of the gastroesophageal junction

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：

主要目的：评估芦康沙妥珠单抗联合特瑞普利单抗治疗一线免疫治疗失败的晚期胃癌或胃食管交界处癌的客观缓解率（ORR），由研究者基于实体瘤疗效评价标准1.1版（RECIST v1.1）进行评估。次要目的： 1.评估芦康沙妥珠单抗联合特瑞普利单抗治疗一线免疫治疗失败的晚期胃癌或胃食管交界处癌的总生存期（OS）； 2.评估芦康沙妥珠单抗联合特瑞普利单抗治疗一线免疫治疗失败的晚期胃癌或胃食管交界处癌的无进展生存期（PFS），由研究者基于RECIST v1.1评估； 3.评估芦康沙妥珠单抗联合特瑞普利单抗治疗一线免疫治疗失败的晚期胃癌或胃食管交界处癌的疾病控制率（DCR）、缓解持续时间（DOR），研究者基于RECIST v1.1评估；评估芦康沙妥珠单抗联合特瑞普利单抗治疗一线免疫治疗失败的晚期胃癌或胃食管交界处癌的安全性和耐受性。

Objectives of Study：

Primary Objective: - To evaluate the objective response rate (ORR) of lukuang satuzumab combined with toripalimab in the treatment of advanced gastric cancer or gastroesophageal junction cancer that has failed first-line immunotherapy, as assessed by the investigator based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary Objectives: 1. To evaluate the overall survival (OS) of lukuang satuzumab combined with toripalimab in the treatment of advanced gastric cancer or gastroesophageal junction cancer that has failed first-line immunotherapy. 2. To evaluate the progression-free survival (PFS) of lukuang satuzumab combined with toripalimab in the treatment of advanced gastric cancer or gastroesophageal junction cancer that has failed first-line immunotherapy, as assessed by the investigator based on RECIST v1.1. 3. To evaluate the disease control rate (DCR) and duration of response (DOR) of lukuang satuzumab combined with toripalimab in the treatment of advanced gastric cancer or gastroesophageal junction cancer that has failed first-line immunotherapy, as assessed by the investigator based on RECIST v1.1. To evaluate the safety and tolerability of lukuang satuzumab combined with toripalimab in the treatment of advanced gastric cancer or gastroesophageal junction cancer that has failed first-line immunotherapy.

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. Age >= 18 years at the time of signing the informed consent form, with no gender restrictions.
2. Histopathologically confirmed unresectable locally advanced, recurrent or metastatic adenocarcinoma of the stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma).
3. Previously received first-line systemic treatment with immune checkpoint inhibitors in combination with chemotherapy, and experienced disease progression confirmed by imaging during or after treatment.
4. At least one measurable target lesion that has not been treated with radiotherapy, as assessed by the investigator according to RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
6. Expected survival >= 12 weeks.
7. Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin or colony-stimulating factor treatment within 2 weeks before the first dose), defined as follows:
a) Blood routine: Neutrophil count (NEUT#) >= 1.5×10^9/L; platelet (PLT) >= 100×10^9/L; hemoglobin >= 80g/L;
b) Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5×ULN; for subjects with liver metastases at baseline, ALT and AST <= 5×ULN; albumin >= 30g/L; total bilirubin (TBIL) <= 1.5×ULN;
c) Renal function: Creatinine clearance >= 50 ml/min (calculated using the standard Cockcroft-Gault formula);
d) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <= 1.5×ULN;
8. For female subjects of childbearing potential and male subjects with partners of childbearing potential, effective medical contraceptive measures must be agreed upon from the time of signing the informed consent form until 6 months after the last dose.
9. Subjects voluntarily join this study, sign the informed consent form, and are able to comply with the visit schedule and related procedures as specified in the protocol.

排除标准：

1.病理组织学检查证实为其他病理类型，如鳞状细胞癌、肉瘤或未分化癌等。 2.入组前4周内参加过其他药物临床试验。 3.既往使用过以TROP2为靶点的治疗，和/或拓扑异构酶I抑制剂的治疗。 4.既往接受PD-1/PD-L1抑制剂一线治疗时出现过以下任一情况： a.治疗开始后3个月内出现进展； b.既往出现过 PD-1/PD-L1抑制剂治疗导致的3级及以上不良反应，2级免疫相关性心脏毒性或任何级别的神经或眼部不良反应； c.在本研究筛选之前，使用前期PD-1/PD-L1抑制剂治疗时的所有不良事件尚未完全缓解或未缓解至1级； d.既往出现过需要使用除糖皮质激素以外的其他免疫抑制剂治疗的不良事件； 5.既往5年内患有其他恶性肿瘤，不包括已治愈的宫颈原位癌、皮肤基底癌或皮肤鳞状细胞癌。 6.已知对本方案药物及其组分有过敏史。 7.人类免疫缺陷病毒（HIV）检查阳性或存在获得性免疫缺陷综合征（艾滋病）病史；已知活动性梅毒感染。 8.研究治疗开始前 2 年内需要系统治疗的活动性自身免疫性疾病，或研究者判断存在可能复发或计划治疗的自身免疫性疾病。 9.有异体器官移植史和异体造血干细胞移植史。 10.首次研究给药之前30天内接种过活疫苗。 11.存在需要类固醇治疗的（非感染性）间质性肺病（ILD）或非感染性肺炎病史，目前有ILD或非感染性肺炎，或筛选时存在无法经影像学检查排除的可疑ILD或非感染性肺炎；肺部并发疾病导致的临床严重肺损害，包括但不限于任何基础肺部疾病（如给药前3个月内的肺栓塞、严重哮喘、重度慢性阻塞性肺疾病、限制性肺疾病、胸腔积液等）或任何可能累及肺部的自身免疫、结缔组织或炎性疾病（即类风湿关节炎、干燥综合征、结节病等），或既往全肺切除术。 12.患有活动性、且过去2年内需要系统性治疗的自身免疫性疾病（激素替代治疗不认为是系统性治疗，如Ⅰ型糖尿病、只需接受甲状腺素替代治疗的甲状腺功能减退症、只需要接受生理剂量的糖皮质激素替代治疗的肾上腺或垂体功能不全）。 13.首次给药前2周内，需要全身性治疗的活动性感染。 14.根据研究者判断，有严重的危害患者安全、或影响患者完成研究的伴随疾病，包括但不限于药物无法控制的高血圧、严重的糖尿病、活动性感染等。 15.有记录的重度干眼综合征，重度睑板腺疾病和或睑缘炎，或存在妨碍延迟角膜愈合的角膜疾病病史。 16.妊娠期、哺乳期女性患者，有生育能力且基线妊娠试验检测阳性的女性患者，在试验药物治疗期间及最后一次用药6个月内不愿意采取有效避孕措施的育龄女性患者。 17.研究者认为患者不适合参加本研究的其他任何情况。

Exclusion criteria：

1. Pathological histological examination confirmed other pathological types, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma, etc. 2. Participated in other drug clinical trials within 4 weeks before enrollment. 3. Previously used TROP2-targeted therapy and/or topoisomerase I inhibitors. 4. Experienced any of the following situations during first-line treatment with PD-1/PD-L1 inhibitors: a. Progression within 3 months after treatment initiation; b. Previously experienced grade 3 or higher adverse reactions caused by PD-1/PD-L1 inhibitors, grade 2 immune-related cardiotoxicity, or any grade of neurological or ocular adverse reactions; c. All adverse events from previous PD-1/PD-L1 inhibitor treatment had not been completely resolved or had not been reduced to grade 1 before the screening of this study; d. Previously experienced adverse events requiring treatment with immunosuppressants other than glucocorticoids. 5. Had other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 6. Known to have an allergy history to the drugs in this protocol and their components. 7. Positive for human immunodeficiency virus (HIV) or with a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection. 8. Active autoimmune diseases requiring systemic treatment within 2 years before the start of study treatment, or the investigator judged that there was a possibility of recurrence or planned treatment of autoimmune diseases. 9. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 10. Received live vaccines within 30 days before the first study administration. 11. Had a history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, currently had ILD or non-infectious pneumonia, or had suspicious ILD or non-infectious pneumonia that could not be excluded by imaging at the time of screening; clinically significant lung damage due to concurrent pulmonary diseases, including but not limited to any underlying pulmonary diseases (such as pulmonary embolism within 3 months before administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue or inflammatory diseases that may involve the lungs (such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or previous total pneumonectomy. 12. Had active autoimmune diseases requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes, hypothyroidism requiring only thyroid hormone replacement therapy, adrenal or pituitary insufficiency requiring only physiological doses of glucocorticoid replacement therapy). 13. Had active infections requiring systemic treatment within 2 weeks before the first administration. 14. According to the investigator's judgment, had serious concomitant diseases that could endanger the patient's safety or affect the patient's completion of the study, including but not limited to uncontrolled hypertension, severe diabetes, active infections, etc. 15. Had a history of severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or had a history of corneal diseases that could impede delayed corneal healing. 16. Pregnant or lactating women, women of childbearing age with a positive baseline pregnancy test, or women of childbearing age who were unwilling to take effective contraceptive measures during the study drug treatment period and within 6 months after the last administration. 17. Other conditions judged by the investigator as unsuitable for the patient to participate in this study.

研究实施时间：

Study execute time：

从 From 2026-03-26 00:00:00至 To 2028-03-25 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-14 00:00:00 至 To 2028-03-25 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	33
Group：	Test group	Sample size：	33
干预措施：	患者将接受芦康沙妥珠单抗（4mg/kg，IV d1 Q2W）和特瑞普利单抗（3 mg/kg，IV d1 Q2W）治疗	干预措施代码：
Intervention：	The patient will receive treatment with lucatumumab (4mg/kg, IV d1 Q2W) and toripalimab (3mg/kg, IV d1 Q2W).	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)：	复旦大学附属华东医院	单位级别：	三甲
Institution hospital：	Huadong Hospital Affiliated to Fudan University	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, ORR	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：	无进展生存期（PFS）	指标类型：	次要指标
Outcome：	progression-free survival (PFS)	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（DCR）	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：	缓解持续时间	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		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）：	未说明
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Not stated
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：	有/Yes
注册人： Name of Registration：	2026-04-14 17:02:55