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：	ChiCTR2600130314
最近更新日期： Date of Last Refreshed on：	2026-08-18 15:50:46
注册时间： Date of Registration：	2026-08-18 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	胃癌患者围手术期治疗效果及免疫分型的前瞻性观察研究
Public title：	A Prospective Observational Study of Perioperative Treatment Outcomes and Immune Classification in Patients with Gastric Cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于新型免疫分子分型胃癌围术期精准免疫-靶向治疗新策略的建立
Scientific title：	Establishment of a Novel Precision Immuno-Targeted Perioperative Treatment Strategy for Gastric Cancer Based on a Novel Immune Molecular Classification
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：	刘凤林	研究负责人：	刘凤林
Applicant：	Liu Fenglin	Study leader：	Liu Fenglin
申请注册联系人电话： Applicant telephone：	+86 21 64041990	研究负责人电话： Study leader's telephone：	+86 21 64041990
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：	liu.fenglin@zs-hospital.sh.cn	研究负责人电子邮件： Study leader's E-mail：	liu.fenglin@zs-hospital.sh.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：	中国上海市徐汇区东安路270号	研究负责人通讯地址：	中国上海市徐汇区东安路270号
Applicant address：	270 Dongan Road, Xuhui District, Shanghai, China	Study leader's address：	270 Dongan Road, Xuhui 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：	复旦大学附属肿瘤医院
Applicant's institution：	Fudan University Shanghai Cancer Center
研究负责人所在单位：	复旦大学附属肿瘤医院
Affiliation of the Leader：	Fudan University Shanghai Cancer Center

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：	2603-Exp409	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：	复旦大学附属肿瘤医院医学伦理委员会
Name of the ethic committee：	Shanghai Cancer Center Institutional Review Board SCCIRB
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-30 00:00:00
伦理委员会联系人：	张玮静
Contact Name of the ethic committee：	Zhang Wei Jing
伦理委员会联系地址：	中国上海市徐汇区东安路270号
Contact Address of the ethic committee：	270 Dongan Road, Xuhui District, Shanghai, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 64175590	伦理委员会联系人邮箱： Contact email of the ethic committee：	andwater@163.com

研究实施负责（组长）单位：

复旦大学附属肿瘤医院

Primary sponsor：

Fudan University Shanghai Cancer Center

研究实施负责（组长）单位地址：

中国上海市徐汇区东安路270号

Primary sponsor's address：

270 Dongan Road, Xuhui 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)：	复旦大学附属肿瘤医院	具体地址：	中国上海市徐汇区东安路270号
Institution hospital：	Fudan University Shanghai Cancer Center	Address：	270 Dongan Road, Xuhui District, Shanghai, China

经费或物资来源：

癌症、心脑血管、呼吸和代谢性疾病防治研究国家科技重大专项

Source(s) of funding：

National Major Science and Technology Project for the Prevention and Treatment of Cancer, Cardiovascular and Cerebrovascular Diseases, Respiratory and Metabolic Diseases

研究疾病：

局部进展期胃腺癌及胃食管结合部腺癌

Target disease：

Locally advanced gastric adenocarcinoma and gastroesophageal junction adenocarcinoma

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

队列研究

Study design：

Cohort study

研究目的：

本研究拟建立多中心胃癌围手术期前瞻性真实世界研究队列，系统收集局部进展期胃癌患者的临床资料、影像学资料、病理资料、生物样本、分子检测信息、治疗过程及长期随访数据，评价患者接受围手术期化疗联合免疫治疗后的病理完全缓解率、主要病理缓解率、R0切除率、安全性及长期生存结局，并比较不同免疫分子亚型患者的治疗反应和预后差异，从而验证新型免疫分子分型对胃癌围手术期治疗疗效及预后的预测价值，为围手术期精准治疗策略的优化提供真实世界证据。

Objectives of Study：

This study aims to establish a multicenter prospective real-world cohort of patients with locally advanced gastric cancer undergoing perioperative treatment. Clinical, imaging, pathological, molecular, treatment, biospecimen, and long-term follow-up data will be systematically collected. The study will evaluate pathological complete response, major pathological response, R0 resection, safety, and long-term survival outcomes following perioperative chemotherapy combined with immunotherapy. Treatment responses and prognostic outcomes will also be compared across different immune molecular subtypes to validate the predictive value of a novel immune molecular classification and provide real-world evidence for optimizing precision perioperative treatment strategies in gastric cancer.

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. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. Age >=18 years on the day of signing the informed consent, regardless of gender;
3. Expected survival >=12 weeks;
4. Patients with gastric adenocarcinoma/gastroesophageal junction adenocarcinoma histologically confirmed by the pathology laboratory at the most recent assessment, with clinical stage cT2-4aN+M0;
5. Able to provide tumor tissue specimens for pathological testing;
6. Assessed by the investigator based on baseline imaging and medical history, expected to be eligible for radical gastrectomy with anticipated R0 resection;
7. No prior anti-tumor therapy for gastric adenocarcinoma/gastroesophageal junction adenocarcinoma;
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to dosing;
9. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) >=50% within 28 days prior to dosing;
10. Organ function levels within 7 days prior to dosing must meet the following requirements:
(1) Bone marrow function: absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90 g/L, and no blood transfusion or blood component transfusion within 14 days prior to the first dose, and no treatment with biological response modifiers (e.g., granulocyte colony-stimulating factors, erythropoietin, etc.) within 7 days prior to the first dose;
(2) Liver function: total bilirubin (TBIL) <=1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5×ULN;
(3) Renal function: serum creatinine (Cr) <=1.5×ULN, or creatinine clearance (Ccr) >=50 mL/min (according to the Cockcroft-Gault formula);
(4) Coagulation function: international normalized ratio (INR) <=1.5×ULN, and activated partial thromboplastin time (APTT) <=1.5×ULN (except for those receiving therapeutic anticoagulants);
11. Fertile males and women of childbearing potential must agree to use effective contraceptive measures from the signing of the informed consent form until 6 months after the last dose of the study drug; women of childbearing potential include premenopausal women and women within 2 years of menopause. A serum pregnancy test must be negative within <=7 days prior to the first dose of the study drug.

排除标准：

1. 既往有其他原发性恶性肿瘤病史；注意：皮肤基底细胞癌、浅表膀胱癌、皮肤鳞状细胞癌或原位宫颈癌除外；或已接受根治性治疗并在治疗5年内未复发的患者可以参加本试验； 2. 研究给药开始前接受过任何针对胃腺癌/胃食管结合部腺癌抗肿瘤治疗，包括化疗、放疗、靶向治疗、免疫治疗以及其他抗肿瘤药物治疗（包括筛选前2周内接受过说明书中明确抗肿瘤成分中药治疗）等； 3. 研究者考虑新辅助治疗阶段需要针对所患肿瘤进行放疗； 4. 研究给药开始前4周内进行过大型手术（如经腹、经胸等重大手术；不包括诊断性穿刺、输液装置植入或胆道支架植入术等小手术）且未完全恢复； 5. 在知情同意前2周内出现活动性消化道出血或出血风险高的患者，在知情同意前6个月内出现胃肠道穿孔/瘘管的患者； 6. 无法保证药物吸收的上消化道梗阻，或功能异常或吸收不良综合征的患者，可影响抗肿瘤药物的吸收； 7. 根据研究者的判断，任何严重或无法控制的全身性疾病，包括药物控制不佳的高血压（收缩压>160 mmHg或舒张压>100 mmHg）、未控制良好的糖尿病等； 8. 有未控制良好的心脏疾病，包括NYHA 2级以上的心力衰竭、不稳定心绞痛、知情前6个月内发生过心肌梗塞、有临床意义的室上性或室性心律失常需要治疗、QT间期延长综合征，如QTcF > 450 ms（男性）或QTcF > 470 ms（女性）； 9. 有活动性感染证据包括乙型肝炎（需同时满足HBsAg阳性，且HBV DNA>=2000 IU/ml，并排除药物或其他原因所致肝炎），丙型肝炎（需同时满足抗-HCV抗体阳性，且HCV RNA结果大于检测下限）或人类免疫缺陷病毒（HIV）感染；未控制的活动性细菌、其他病毒、真菌、立克次体或寄生虫感染，除非在研究药物给药前获得治疗并消退； 10. 对抗肿瘤药物任一组分有过敏史，既往对大分子蛋白制剂/单克隆抗体>=3级的过敏史； 11. 原发性免疫缺陷病史者或具有活动性自身免疫性疾病者，正在使用免疫抑制剂、或全身激素治疗（剂量>=10 mg/天的泼尼松或其他等效激素），并在入组前2周内仍在继续使用；注意：I型糖尿病、激素替代治疗稳定的甲状腺功能减退症（包括自身免疫性甲状腺病导致的甲状腺功能减退症）、不需要全身治疗的银屑病或白癜风的患者可以入组； 12. 既往有或合并间质性肺炎、重度慢性阻塞性肺病、重度肺功能不全、有症状的支气管痉挛等病史； 13. 血清妊娠试验阳性或哺乳期女性不同意在研究期间及接受试验药物结束后6个月采取充分的避孕措施； 14. 研究者认为不适合参加本临床试验的其他情况。

Exclusion criteria：

1. Prior history of other primary malignancies; note: patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix are excluded; or patients who have received curative treatment and have not relapsed within 5 years of treatment may participate in this trial; 2. Received any anti-tumor therapy for gastric adenocarcinoma/gastroesophageal junction adenocarcinoma prior to the start of study drug administration, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, and other anti-tumor drug treatments (including traditional Chinese medicine with clear anti-tumor ingredients as stated in the package insert within 2 weeks prior to screening); 3. Radiotherapy is considered necessary by the investigator for the target tumor during the neoadjuvant treatment phase; 4. Underwent major surgery (e.g., transabdominal, transthoracic, or other major surgeries; excluding minor procedures such as diagnostic puncture, implantation of infusion devices, or biliary stent placement) within 4 weeks prior to the start of study drug administration and has not fully recovered; 5. Patients with active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to informed consent, or patients with gastrointestinal perforation/fistula within 6 months prior to informed consent; 6. Upper gastrointestinal obstruction that prevents drug absorption, or patients with functional abnormalities or malabsorption syndrome that may affect the absorption of anti-tumor drugs; 7. Any severe or uncontrolled systemic disease as judged by the investigator, including poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), poorly controlled diabetes, etc.; 8. Uncontrolled cardiac diseases, including heart failure of NYHA class >2, unstable angina, myocardial infarction within 6 months prior to informed consent, clinically significant supraventricular or ventricular arrhythmias requiring treatment, QT prolongation syndrome, e.g., QTcF > 450 ms (male) or QTcF > 470 ms (female); 9. Evidence of active infection including hepatitis B (requires both HBsAg positive and HBV DNA >=2000 IU/ml, excluding hepatitis due to drugs or other causes), hepatitis C (requires both anti-HCV antibody positive and HCV RNA above the lower limit of detection), or human immunodeficiency virus (HIV) infection; uncontrolled active bacterial, other viral, fungal, rickettsial, or parasitic infections, unless treated and resolved before study drug administration; 10. History of allergy to any component of the anti-tumor drug, or history of >=grade 3 allergy to macromolecular protein preparations/monoclonal antibodies; 11. History of primary immunodeficiency or active autoimmune diseases, currently using immunosuppressants, or systemic corticosteroid therapy (dose >=10 mg/day of prednisone or other equivalent hormones), and continued use within 2 weeks prior to enrollment; note: patients with type I diabetes, stable hypothyroidism on hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis not requiring systemic treatment, or vitiligo may be enrolled; 12. Prior or concurrent history of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.; 13. Positive serum pregnancy test or lactating women who do not agree to take adequate contraceptive measures during the study period and within 6 months after the last dose of study drug; 14. Other conditions that the investigator deems unsuitable for participation in this clinical trial.

研究实施时间：

Study execute time：

从 From 2026-03-01 00:00:00至 To 2030-02-28 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-08-28 00:00:00 至 To 2028-02-29 00:00:00

干预措施：

Interventions：

组别：	观察组	样本量：	300
Group：	Observation group	Sample size：	300
干预措施：	无	干预措施代码：
Intervention：	None	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)：	复旦大学附属肿瘤医院	单位级别：	三级甲等
Institution hospital：	Fudan University Shanghai Cancer Center	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	天津	市(区县)：
Country：	China	Province：	Tianjin	City：
单位(医院)：	天津市肿瘤医院	单位级别：	三级甲等
Institution hospital：	Tianjin Medical University Cancer Institute and Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京肿瘤医院（北京大学肿瘤医院）	单位级别：	三级甲等
Institution hospital：	Peking University Cancer Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	中国医学科学院北京协和医院	单位级别：	三级甲等
Institution hospital：	Peking Union Medical College Hospital, Chinese Academy of Medical	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	主要病理缓解率（MPR）、R0切除率及肿瘤退缩分级评分（TRG）	指标类型：	次要指标
Outcome：	Major pathological response rate, R0 resection rate, and tumor regression grade	Type：	Secondary indicator
测量时间点：	根治性手术后病理评估完成时	测量方法：	根据胃癌根治性手术切除标本进行病理评估。MPR根据术后残余存活肿瘤细胞比例进行判定；R0切除率根据手术记录及术后病理切缘情况评价；TRG根据肿瘤退缩程度进行分级评价。
Measure time point of outcome：	After completion of postoperative pathological assessment	Measure method：	MPR was assessed based on the proportion of residual viable tumor cells in surgical specimens. R0 resection was determined according to surgical records and pathological margin status. TRG was evaluated according to pathological tumor regression assessment.

指标中文名：	无事件生存期（EFS）及12个月/24个月EFS率	指标类型：	次要指标
Outcome：	Event-free survival and 12-month/24-month EFS rate	Type：	Secondary indicator
测量时间点：	从患者入组开始至疾病进展、复发、死亡或末次随访	测量方法：	记录患者入组日期、疾病进展、复发及死亡时间，采用Kaplan-Meier方法进行生存分析，计算EFS中位时间及12个月、24个月EFS率。
Measure time point of outcome：	From study enrollment until disease progression, recurrence, death, or last follow-up	Measure method：	EFS was calculated from enrollment to disease progression, recurrence, death, or last follow-up. Kaplan-Meier analysis was used to estimate median EFS and 12-month/24-month EFS rates.

指标中文名：	病理完全缓解率（pCR）	指标类型：	主要指标
Outcome：	Pathological complete response rate	Type：	Primary indicator
测量时间点：	根治性手术后病理评估完成时	测量方法：	根据胃癌根治性手术切除标本及区域淋巴结病理结果进行评价。病理完全缓解定义为原发肿瘤及区域淋巴结中均无存活肿瘤细胞（ypT0N0）。
Measure time point of outcome：	After completion of postoperative pathological assessment	Measure method：	Pathological complete response was assessed based on pathological examination of resected primary tumor and regional lymph nodes. pCR was defined as the absence of viable tumor cells in both primary tumor and lymph nodes (ypT0N0).

指标中文名：	客观缓解率（ORR）	指标类型：	次要指标
Outcome：	Objective response rate	Type：	Secondary indicator
测量时间点：	术前治疗结束后手术前影像学评估时	测量方法：	依据RECIST 1.1标准，通过CT、MRI或PET-CT影像学检查评价肿瘤疗效，计算达到完全缓解（CR）和部分缓解（PR）的患者比例。
Measure time point of outcome：	After completion of preoperative treatment and before surgery	Measure method：	ORR was assessed according to RECIST version 1.1 criteria based on imaging evaluation, including complete response and partial response.

指标中文名：	肿瘤免疫微环境与pCR率的相关性	指标类型：	次要指标
Outcome：	Association between tumor immune microenvironment and pathological complete response rate	Type：	Secondary indicator
测量时间点：	治疗前肿瘤组织检测完成后及术后病理结果获得后	测量方法：	通过免疫相关检测及多组学分析评价肿瘤免疫微环境特征，并分析其与pCR之间的相关性。
Measure time point of outcome：	After baseline tumor immune microenvironment assessment and postoperative pathological evaluation	Measure method：	Tumor immune microenvironment characteristics were assessed using immune-related assays and multi-omics analyses, and their associations with pCR were evaluated.

指标中文名：	手术相关并发症发生率	指标类型：	次要指标
Outcome：	Incidence of surgery-related complications	Type：	Secondary indicator
测量时间点：	根治性手术后30天内	测量方法：	根据手术记录及术后随访资料，记录术后发生的手术相关并发症，包括并发症类型、发生时间及严重程度。
Measure time point of outcome：	Within 30 days after curative surgery	Measure method：	Surgery-related complications were collected from surgical records and postoperative follow-up, including complication type, onset time, and severity.

指标中文名：	治疗相关不良事件（AE）、严重不良事件（SAE）的发生率及严重程度	指标类型：	次要指标
Outcome：	Incidence and severity of treatment-related adverse events and serious adverse events	Type：	Secondary indicator
测量时间点：	研究治疗开始至末次随访期间	测量方法：	依据NCI-CTCAE v5.0标准评价不良事件严重程度，采用MedDRA进行事件编码，统计AE、SAE发生率及严重程度，同时记录AE导致的剂量暂停率、剂量终止率及死亡发生率。
Measure time point of outcome：	From initiation of study treatment to the last follow-up	Measure method：	Adverse events were assessed according to NCI-CTCAE version 5.0 and coded using MedDRA. The incidence and severity of AE and SAE, as well as treatment interruption, discontinuation, and death rates due to AE were summarized.

指标中文名：	生物标志物与pCR率的相关性	指标类型：	次要指标
Outcome：	Association between biomarkers and pathological complete response rate	Type：	Secondary indicator
测量时间点：	治疗前肿瘤组织检测完成后及术后病理结果获得后	测量方法：	检测肿瘤组织HER2 IHC表达、ISH状态及PD-L1 CPS评分，并分析不同生物标志物状态与pCR发生情况之间的相关性。
Measure time point of outcome：	After baseline biomarker assessment and postoperative pathological evaluation	Measure method：	HER2 IHC expression, ISH status, and PD-L1 CPS score were evaluated, and their associations with pCR were analyzed.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	治疗前胃镜活检组织	组织：
Sample Name：	Pretreatment gastroscopic biopsy tissue	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	NA	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:

不公开/Private

盲法：	无
Blinding：	None

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）：	不适用
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Not applicable
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：	本研究采用电子数据采集系统（Electronic Data Capture, EDC）进行数据采集和管理。各研究中心研究人员根据病例报告表（CRF）要求录入受试者临床资料、影像学资料、病理信息、生物样本检测结果及随访信息。研究数据由北京大学肿瘤医院负责EDC系统管理和数据质量控制，各中心按照统一的数据管理规范进行数据录入、核查和维护。所有数据采用受试者编号进行去标识化处理，以保证数据安全性和可溯源性。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data will be collected and managed using an electronic data capture (EDC) system. Investigators from each participating center will enter clinical information, imaging data, pathological information, biospecimen analysis results, and follow-up data according to the case report form (CRF). The EDC system will be managed by Beijing Cancer Hospital, which will be responsible for data quality control and standardized data management. All data will be de-identified using subject identification numbers to ensure data security and traceability.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-08-18 15:50:36