ChiCTR2600123881 版本V1.0 版本创建时间2026/04/30 15:37:33 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：

ChiCTR2600123881 

最近更新日期：

Date of Last Refreshed on：

2026-04-30 15:35:59 

注册时间：

Date of Registration：

2026-04-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

局部进展期胃上部/胃食管结合部腺癌新辅助PD?1抑制剂联合SOX化疗±短程放射治疗（豁免区域淋巴结照射）的前瞻性、多中心、随机对照研究

Public title：

Neoadjuvant Serplulimab and SOX Chemotherapy with or without Lymph Node-Sparing Short-Course Radiotherapy for Locally Advanced Upper Gastric Cancer or Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

局部进展期胃上部/胃食管结合部腺癌新辅助PD?1抑制剂联合SOX化疗±短程放射治疗（豁免区域淋巴结照射）的前瞻性、多中心、随机对照研究

Scientific title：

Neoadjuvant Serplulimab and SOX Chemotherapy with or without Lymph Node-Sparing Short-Course Radiotherapy for Locally Advanced Upper Gastric Cancer or Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Randomized Controlled Trial

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：

周颖彬 

研究负责人：

胡俊波 

Applicant：

zhouyingbin 

Study leader：

Hu Junbo 

申请注册联系人电话：

Applicant telephone：

+86 13647218935

研究负责人电话：

Study leader's telephone：

+86 27 83662379

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：

2363057368@qq.com

研究负责人电子邮件：

Study leader's E-mail：

jbhu@tjh.tjmu.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：

湖北省武汉市硚口区解放大道1095号

研究负责人通讯地址：

湖北省武汉市硚口区解放大道1095号

Applicant address：

No. 1095 Jiefang Avenue, Qiaokou District, Wuhan City, Hubei Province

Study leader's address：

1095# Jiefang Avenue, Qiaokou District, Wuhan, Hubei,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：

华中科技大学同济医学院附属同济医院

Applicant's institution：

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

研究负责人所在单位：

华中科技大学同济医学院附属同济医院

Affiliation of the Leader：

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

TJ-IRB202603105

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：

华中科技大学同济医学院附属同济医院医学伦理委员会

Name of the ethic committee：

Institutional Review Board of Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

伦理委员会批准日期：

Date of approved by ethic committee：

2026-03-25 00:00:00

伦理委员会联系人：

周璞

Contact Name of the ethic committee：

Zhou Pu

伦理委员会联系地址：

湖北省武汉市硚口区解放大道1095号

Contact Address of the ethic committee：

No. 1095 Jiefang Avenue, Qiaokou District, Wuhan City, Hubei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 27 83662379

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zhoupu_tjh@163.com

研究实施负责（组长）单位：

华中科技大学同济医学院附属同济医院

Primary sponsor：

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

湖北省武汉市硚口区解放大道1095号

Primary sponsor's address：

No. 1095 Jiefang Avenue, Qiaokou District, Wuhan City, Hubei 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)：

湖北省

市(区县)：

Country：

China

Province：

Hubei

City：

单位(医院)：

华中科技大学同济医学院附属同济医院

具体地址：

湖北省武汉市硚口区解放大道1095号

Institution
hospital：

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

Address：

No. 1095 Jiefang Avenue, Qiaokou District, Wuhan City, Hubei Province

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：

Noncommunicable Chronic Diseases-National Science and Technology Major Project

Target disease：

Locally Advanced Proximal Gastric or Gastroesophageal Junction Adenocarcinoma

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：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的：比较短程豁免淋巴结放疗序贯化免治疗与化免治疗在局部进展期胃上部/胃食管结合部腺癌患者中新辅助治疗疗效与安全性 次要目的：探索局部进展期胃上部/胃食管结合部腺癌新辅助放疗联合化学免疫治疗敏感人群筛选指标  

Objectives of Study：

Primary objective: To compare the efficacy and safety of short-course radiotherapy (with elective nodal irradiation omitted) followed by chemo-immunotherapy versus chemo-immunotherapy alone as neoadjuvant treatment in patients with locally advanced adenocarcinoma of the proximal stomach and gastroesophageal junction (GEJ).Secondary objective: To explore biomarkers/selection criteria for identifying patients with locally advanced proximal gastric/GEJ adenocarcinoma who are more likely to be sensitive to neoadjuvant radiotherapy combined with chemo-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：

1. 受试者自愿加入本研究，能完成知情同意书的签署，且依从性良好； 2. 年龄18-75岁（签署知情同意书时），男女不限； 3. 经组织学和/或细胞学确诊的腺癌，根据AJCC第8版标准诊断局部进展期，根据超声内镜或增强CT / MRI扫描cTNM诊断为cT3-4或N+M0，且同意接受新辅助治疗，研究者评估病灶可切除或潜在可切除；经MDT评估拟行根治性切除并计划实施标准D2淋巴结清扫； 4. 原发病灶部位限制： 1）胃食管结合部腺癌：Siewert II–III 型； 2）胃上部胃癌：肿瘤下缘位于胃体上1/3以内，主要累及贲门、胃底或胃体上段； 5. 既往未接受过针对当前疾病的系统性治疗，包括抗肿瘤放化疗/免疫治疗等； 6. ECOG 评分 0-1 分； 7. 预计生存期≥ 6个月； 8. 术前胸、腹、盆 CT 及FAPI PET或PET-CT排除远处转移； 9. 主要器官功能良好，符合下列标准： 1）血常规检查（14 天内未输血、未使用造血刺激因子类药物纠正状态下）：血红蛋白（Hb）≥90g/L；绝对中性粒细胞计数（ANC）≥1.5×10^9/L；血小板（PLT）≥80×10^9/L； 2）生化检查：谷丙转氨酶（ALT）及谷草转氨酶（AST）≤2.5×ULN；血清总胆红素（TBIL）≤1.5×ULN；血清肌酐（Cr）≤1.5×ULN，或肌酐清除率≥60mL/min； 3）凝血功能：活化部分凝血活酶时间（APTT）、国际标准化比值（INR）、凝血酶原时间（PT）≤1.5×ULN； 4）多普勒超声评估：左室射血分数（LVEF）≥50%； 10. 医生临床判定具有足够的器官功能； 11. 有生育能力的受试者在本研究期间和研究结束后120天内，必须采用适当的方法避孕，在研究入组前的7天内血清妊娠试验阴性，且必须为非哺乳期受试者。

Inclusion criteria

1. The participant voluntarily joins this study, is able to complete the signing of the informed consent form, and demonstrates good compliance; 2. Age 18-75 years (at the time of signing the informed consent), regardless of gender; 3. Adenocarcinoma confirmed by histology and/or cytology, diagnosed as locally advanced according to the AJCC 8th edition criteria, with cTNM staged as cT3-4 or N M0 based on endoscopic ultrasound or contrast-enhanced CT/MRI, and the patient agrees to receive neoadjuvant therapy; the lesion is assessed by the investigator as resectable or potentially resectable; after MDT evaluation, radical resection is planned with standard D2 lymph node dissection. 4. Primary lesion site restrictions: (1) Adenocarcinoma of the gastroesophageal junction: Siewert type II–III; (2) Upper stomach cancer: the lower edge of the tumor is located within the upper third of the stomach, mainly involving the cardia, fundus, or upper part of the stomach body; 5. Has not previously received systemic treatment for the current disease, including anti-tumor radiotherapy/chemotherapy or immunotherapy; 6. ECOG score 0-1; 7. Estimated survival period >= 6 months; 8. Preoperative chest, abdominal, and pelvic CT, as well as FAPI PET or PET-CT, to rule out distant metastasis; 9. Major organ function is satisfactory and meets the following criteria: (1) Complete blood count (without blood transfusion or use of hematopoietic growth factors within 14 days to correct status): hemoglobin (Hb) >=90 g/L; absolute neutrophil count (ANC) >=1.5 × 10^9/L; platelets (PLT) >=80 × 10^9/L; (2) Biochemical tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 × ULN; total bilirubin (TBIL) <=1.5 × ULN; serum creatinine (Cr) <=1.5 × ULN, or creatinine clearance >=60 mL/min; (3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) <=1.5 × ULN; 4) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >=50%. 10. The doctor clinically determines that there is sufficient organ function; 11. Subjects of reproductive potential must use appropriate contraception during the study and for 120 days after the study ends, have a negative serum pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding.

排除标准：

1. 入组前4周内进行放疗，或8周内进行放射性核素治疗；
2. 入组前6个月内：胃食管静脉曲张、严重溃疡、未愈合伤口、胃肠穿孔、瘘管、肠梗阻、腹腔内脓肿或急性胃肠道出血；
3. 首次给药前5年内诊断为胃癌之外的其他恶性疾病（不包括经过根治的皮肤基底细胞癌、皮肤鳞状上皮癌、和/或经过根治性切除的原位癌）；
4. 存在远处转移（M1），包括但不限于：腹膜转移（影像学或腹腔镜证实）、腹水或腹腔冲洗细胞学阳性、肝/肺/骨等脏器转移；影像学提示腹主动脉旁淋巴结（No.16）转移者；
5. 影像学提示区域淋巴结负荷过高：可疑/阳性淋巴结累及≥3个解剖站位；或多发淋巴结融合/成团（matted nodes）；或任一淋巴结短轴≥15 mm；
6. 肿瘤病灶具有严重出血倾向（如存在活动性深大溃疡病灶、签署知情同意书前2个月内呕血或黑便病史、经研究者判断存在消化道大出血危险等）或研究用药前4周曾接受输血治疗；
7. 无法吞咽口服药物、吸收不良综合征或其他影响胃肠道吸收的状况；
8. 当前正在参与干预性临床研究治疗，或在首次给药前4周内接受过其他研究药物或使用过研究器械治疗；
9. 既往接受过胃癌的全身性或局部抗肿瘤治疗，包括治愈性手术、化疗、放疗、免疫疗法（如免疫检查点抑制剂、激动剂或细胞疗法）、生物制剂或小分子靶向药物；
10. 首次给药前2周内接受过具有抗肿瘤适应症的中成药或免疫调节作用的药物（包括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）系统性全身治疗；
11. 首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、糖皮质激素或免疫抑制剂）的活动性自身性免疫疾病。替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性糖皮质激素等）不视为全身性治疗；
12. 研究首次给药前7天内正在接受全身性糖皮质激素治疗（不包括喷鼻、吸入性或其他途径的局部糖皮质激素）或任何其他形式的免疫抑制疗法；注：允许使用生理剂量的糖皮质激素（≤10 mg/天的泼尼松或等效药物）；允许因化疗止吐、造影剂过敏预处理或其他短程医学必要用途使用短疗程糖皮质激素；
13. 已知异体器官移植（角膜移植除外）或异体造血干细胞移植；
14. 已知对本研究中使用药物过敏者；
15. 周围神经病变≥2级；
16. 已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）；
17. 活动性乙型肝炎或丙型肝炎受试者（HBsAg阳性同时检测到HBV DNA 滴度高于正常值上限；HCVAb阳性同时检测到HCV RNA滴度高于正常值上限（注：HBV DNA阳性受试者若愿意在研究期间全程接受抗病毒治疗且入组前已开始治疗，可视情况入组，需与感染科会诊）；
18. 首次给药之前（第1周期，第1天）30 天内接种过活疫苗；允许首次给药前30天内接受针对季节性流感的注射用灭活病毒疫苗；但是不允许接受鼻内用药的减毒活流感疫苗；
19. 妊娠或哺乳期妇女；
20. 存在任何严重或不能控制的全身性疾病，例如： 1）静息心电图在节律、传导或形态上出现有重大且症状严重难以控制的异常，如完全性左束支传导阻滞，Ⅱ度以上心脏传导阻滞，室性心律失常或心房颤动； 2）不稳定型心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级≥ 2级的慢性心衰； 3）在入选治疗前6个月内发生过任何动脉血栓、栓塞或缺血，如心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等； 4）高血压长期控制不理想（收缩压＞160 mmHg，舒张压＞100 mmHg）； 5）首次给药前1年内存在需要糖皮质激素治疗的非感染性肺炎病史，或当前存在临床活动性间质性肺病； 6）有重大出血性疾病或凝血功能障碍史；当前或既往长期抗凝治疗（例如，CHADS2评分≥2的房颤）； 7）活动性肺结核； 8）有炎症性肠病史（如克罗恩病、溃疡性结肠炎）或慢性腹泻； 9）治疗前30天内接受重大手术或重大创伤；治疗前3天内进行轻微局部手术（不含通过外周静脉置入中心静脉导管）； 10）存在需要全身性治疗的活动性或未能控制的感染； 11）存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻； 12）无法控制的合并症包括但不限于失代偿肝硬化、肾病综合征、失控代谢紊乱、严重活跃性消化性溃疡或胃炎，或妨碍方案遵循或知情同意的精神/社会状况； 13）糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）； 14）尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者；
21. 已知有精神疾病、物质滥用、酗酒或药物成瘾的病史；
22. 有可能干扰试验结果、妨碍受试者全程参与研究的病史或疾病证据、治疗或实验室检查值异常，或研究者认为其他不适合入组的情况研究者认为存在其他潜在风险不适合参加本研究；
23. 由肿瘤引起的局部或全身性疾病，或高医疗风险或预后不明的肿瘤相关并发症（例如白细胞反应导致白细胞>20 × 10?/L，恶病质，筛查前3个月体重减轻>10%），或BMI≤18）。

Exclusion criteria：

1. Undergo radiotherapy within 4 weeks before enrollment, or radionuclide therapy within 8 weeks; 2. Within 6 months before enrollment: esophageal or gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, fistulas, intestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding; 3. Diagnosis of malignancies other than gastric cancer within 5 years prior to first administration (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ); 4. Presence of distant metastasis (M1), including but not limited to: peritoneal metastasis (confirmed by imaging or laparoscopy), ascites or positive peritoneal lavage cytology, metastasis to organs such as liver, lung, or bone; cases where imaging suggests metastasis to para-aortic lymph nodes (No.16); 5. Imaging suggests excessive regional lymph node burden: suspicious/positive lymph node involvement in >=3 anatomical stations; or multiple lymph nodes are fused/form a cluster (matted nodes); or any lymph node has a short axis >=15 mm; 6. The tumor lesion has a serious tendency to bleed (such as the presence of an active deep large ulcer, a history of vomiting blood or black stools within 2 months before signing the informed consent, or a risk of major gastrointestinal bleeding as determined by the investigator), or has received blood transfusion treatment within 4 weeks prior to the study medication; 7. Inability to swallow oral medications, malabsorption syndrome, or other conditions affecting gastrointestinal absorption; 8. Currently participating in interventional clinical research treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration; 9. Previously received systemic or local anti-tumor treatment for gastric cancer, including curative surgery, chemotherapy, radiotherapy, immunotherapy (such as immune checkpoint inhibitors, agonists, or cell therapy), biological agents, or small molecule targeted drugs; 10. Systemic therapy with traditional Chinese medicine having anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukins, except for local use to control pleural effusion) within 2 weeks prior to the first dose; 11. Active autoimmune disease that required systemic treatment (such as disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first administration. Replacement therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatment; 12. The participant is receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other forms of topical corticosteroids) or any other form of immunosuppressive therapy within the 7 days prior to the first study drug administration; Note: The use of physiological doses of corticosteroids (<=10 mg/day of prednisone or equivalent) is allowed; short courses of corticosteroids are allowed for medically necessary reasons such as chemotherapy-induced nausea, premedication for contrast agent allergy, or other short-term medical needs; 13. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 14. Known allergies to medications used in this study; 15. Peripheral neuropathy >= grade 2; 16. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 17. Subjects with active hepatitis B or hepatitis C (HBsAg positive with HBV DNA levels above the upper limit of normal; HCVAb positive with HCV RNA levels above the upper limit of normal (Note: Subjects who are HBV DNA positive may be enrolled if they are willing to undergo full antiviral treatment throughout the study and have already started treatment before enrollment, subject to consultation with an infectious disease specialist); 18. Within 30 days before the first dose (Cycle 1, Day 1), live vaccines were administered; inactivated influenza vaccines for injection against seasonal flu are allowed within 30 days before the first dose; however, intranasal live attenuated influenza vaccines are not allowed; 19. Pregnant or breastfeeding women; 20. Presence of any severe or uncontrollable systemic disease, such as: (1) Significant and symptomatic abnormalities on resting electrocardiogram in rhythm, conduction, or morphology that are difficult to control, such as complete left bundle branch block, second-degree or higher heart conduction block, ventricular arrhythmias, or atrial fibrillation; (2) Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class >= 2; (3) Any arterial thrombosis, embolism, or ischemia within 6 months prior to treatment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; (4) Long-term poorly controlled hypertension (systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg); (5) History of non-infectious pneumonia requiring corticosteroid therapy within 1 year before initial dosing, or currently active interstitial lung disease; (6) Significant bleeding disorders or a history of coagulopathy; current or past long-term anticoagulant therapy (e.g., atrial fibrillation with CHADS2 score >=2); (7) Active pulmonary tuberculosis; (8) History of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or chronic diarrhea; (9) Major surgery or major trauma within 30 days prior to treatment; minor local surgery within 3 days prior to treatment (excluding central venous catheter placement via peripheral vein); (10) Presence of active or uncontrolled infection requiring systemic therapy; (11) Presence of clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction; (12) Uncontrolled comorbidities including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer or gastritis, or mental/social conditions that interfere with protocol compliance or informed consent; (13) Poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L); (14) Urinalysis indicating proteinuria >=++, confirmed by 24-hour urine protein quantification >1.0 g. 21. Known history of mental illness, substance abuse, alcoholism, or drug addiction; 22. Any history or evidence of disease that may interfere with the trial results, hinder the subject's full participation in the study, abnormal treatment or laboratory test results, or any other condition that the investigator considers unsuitable for enrollment. The investigator believes that there are other potential risks making the subject unsuitable to participate in this study; 23. Local or systemic diseases caused by tumors, or tumor-related complications with high medical risk or uncertain prognosis (for example, leukocyte response resulting in leukocytes >20 × 10^9/L, cachexia, weight loss >10% in the three months before screening), or BMI <=18).

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2031-05-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-05-01 00:00:00 至 To 2028-05-01 00:00:00  

干预措施：

Interventions：

组别：

豁免淋巴结SCRT序贯SOX联合斯鲁利单抗治疗组

样本量：

73

Group：

Neoadjuvant Serplulimab and SOX Chemotherapy with Lymph Node-Sparing Short-Course Radiotherapy

Sample size：

干预措施：

新辅助豁免淋巴结SCRT序贯SOX联合斯鲁利单抗治疗

干预措施代码：

Intervention：

Neoadjuvant Serplulimab and SOX Chemotherapy with Lymph Node-Sparing Short-Course Radiotherapy

Intervention code：

组别：

SOX联合斯鲁利单抗治疗组

样本量：

73

Group：

Neoadjuvant Serplulimab and SOX Chemotherapy

Sample size：

干预措施：

新辅助SOX联合斯鲁利单抗治疗

干预措施代码：

Intervention：

Neoadjuvant Serplulimab and SOX Chemotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

  

Country：

China 

Province：

Hubei 

City：

 

单位(医院)：

华中科技大学同济医学院附属同济医院 

单位级别：

三级甲等 

Institution
hospital：

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 北京市 

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：

Beijing Cancer Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

浙江大学医学院附属第二医院 

单位级别：

三级甲等 

Institution
hospital：

The Second Affiliated Hospital Zhejiang University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

病理完全缓解率

指标类型：

主要指标

Outcome：

Pathological Complete Response, pCR

Type：

Primary indicator

测量时间点：

手术治疗后

测量方法：

病理结果

Measure time point of outcome：

After surgical treatment

Measure method：

Pathology results

指标中文名：

R0切除率

指标类型：

次要指标

Outcome：

R0 resection rate

Type：

Secondary indicator

测量时间点：

手术治疗后

测量方法：

病理结果

Measure time point of outcome：

After surgical treatment

Measure method：

Pathology results

指标中文名：

不良反应发生率

指标类型：

次要指标

Outcome：

Incidence of adverse reactions

Type：

Secondary indicator

测量时间点：

每个治疗周期结束后

测量方法：

肿瘤治疗常见不良反应分级

Measure time point of outcome：

At the end of each treatment cycle

Measure method：

CTCAE

指标中文名：

3年无事件生存期

指标类型：

次要指标

Outcome：

3-year event-free survival

Type：

Secondary indicator

测量时间点：

治疗开始后3年

测量方法：

肿瘤标志物检查、影像学检查及胃肠镜检查

Measure time point of outcome：

3 years after the start of treatment

Measure method：

Tumor marker tests, imaging examinations, and gastrointestinal endoscopy

指标中文名：

主要病理缓解率

指标类型：

次要指标

Outcome：

Major Pathological Response, MPR

Type：

Secondary indicator

测量时间点：

手术治疗后

测量方法：

病理结果

Measure time point of outcome：

After surgical treatment

Measure method：

Pathology results

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

Quality of Life

Type：

Secondary indicator

测量时间点：

每个治疗周期结束后

测量方法：

EORTC QLQ-C30 (version 3)、EORTC QLQ-STO22、EQ-5D-5L

Measure time point of outcome：

At the end of each treatment cycle

Measure method：

EORTC QLQ-C30 (version 3)、EORTC QLQ-STO22、EQ-5D-5L

指标中文名：

3年无病生存

指标类型：

次要指标

Outcome：

3-year disease-free survival

Type：

Secondary indicator

测量时间点：

治疗开始后3年

测量方法：

肿瘤标志物检查、影像学检查及胃肠镜检查

Measure time point of outcome：

3 years after the start of treatment

Measure method：

Tumor marker tests, imaging examinations, and gastrointestinal endoscopy

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：

治疗过程中

测量方法：

随访

Measure time point of outcome：

During the treatment

Measure method：

Follow-up

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

胃镜病灶活检组织

组织：

Sample Name：

Gastroscopic biopsy tissue

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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）：

本研究受试者随机号的产生采用区组随机化方法。 由与本研究统计无关的独立统计师选取合适的区组长度，给定随机种子数，通过SAS9.4统计软件，按照1:1比例产生受试者所接受治疗组（队列1、队列2）的随机序列，生成随机号001~146及其对应治疗分组，即本研究的受试者随机表。 本研究的随机序列，连同产生随机数的种子数、区组长度等参数形成的随机表文件，密封后由申办单位保存，任何人不得私自拆阅随机表文件，直

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

In this study, the random number of subjects was generated by block randomization method. Independent statisticians unrelated to the statistics of this study selected appropriate block size, given the number of random seeds, and used SAS9.4 statistical software to generate random sequences of the treatment groups (test group and control group) received by subjects in a 1:1 ratio, generating random numbers 001~146 and corresponding treatment groups, that is, the subject randomization table of this study.

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：

开放标签

Blinding：

Open-label study

是否共享原始数据：

IPD sharing

Yes

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）：

论文发表3年后共享部分信息及数据，,国家人口健康科学数据中心 (https://www.ncmi.cn/)

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

partial data will be shared 3 years after the study was completed and end in 5 years,National Population Health Data Center (https://www.ncmi.cn/)

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：

病例报告表由研究者填写，每个入选病例必须完成病例报告表。完成的病例报告表由临床监查员审查后，移交数据管理员，在REDCap数据管理系统中进行数据录入与管理工作。

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

The case report form shall be completed by the investigator. The completed case report form is reviewed by the clinical monitor and transferred to the data manager for data entry and management in the REDCap data management system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-30 15:35:59