RECRUITING Phase 3 ClinicalTrials.gov

Radical Surgery Versus Non-Surgery in Gastric Cancer Patients With Peritoneal Metastasis After Successful Conversion Therapy

Sponsor: Hua Huang, MD, PhD • ClinicalTrials.gov ID: NCT07789184

Registry updated: 2026-10-16

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Description

The goal of this clinical trial is to learn if radical surgery improves prognosis and quality of life compared with continued standard non-surgical treatment in gastric cancer patients with peritoneal metastasis who have achieved successful conversion therapy. The main questions it aims to answer are: * Does radical surgery prolong overall survival in patients who achieve successful conversion therapy? * Does radical surgery provide better or at least comparable quality of life and safety outcomes compared with continued standard treatment? Researchers will compare radical surgery versus continued standard systemic treatment to see whether radical surgery provides superior clinical benefit for patients after successful conversion therapy. Participants will: * Initial laparoscopic exploration confirms CY0P1 or CY1P1, absence of distant organ metastasis, a PCI ≤ 20, and presence or absence of ascites. * Receive conversion therapy (chemotherapy, targeted/immunotherapy, intraperitoneal therapy, etc.) per standard guidelines, tailored to the patient's condition and molecular-pathological profile * If clinical conversion is confirmed, undergo a second laparoscopic exploration to verify successful conversion * If successful conversion is confirmed (peritoneal lesions cleared or markedly regressed with negative biopsy, no ascites or distant metastases, R0-resectable primary tumor, and improved patient condition), be randomized 1:1 to either the surgery group or the standard treatment group * In the surgery group, undergo curative gastrectomy with D2 lymphadenectomy during the second laparoscopy, followed by adjuvant therapy and maintenance treatment * In the standard treatment group, continue systemic therapy without surgery, with maintenance treatment and salvage surgery permitted if clinically indicated * Complete quality of life questionnaires at predefined time points * Be followed up for survival, disease progression, adverse events and medical resource use outcomes

Interventions

Radical Gastrectomy with D2 Lymphadenectomy (Procedure)
Patients undergo curative gastrectomy with D2 lymphadenectomy (laparoscopic, robotic, or open) during second-look laparoscopy after successful conversion therapy. Postoperatively, they receive adjuvant systemic therapy (continuing the preoperative regimen or MDT-modified protocol) for up to 8 cycles total, followed by maintenance therapy for up to 1 year after randomization, or until disease progression, unacceptable toxicity, or withdrawal.
Standard Systemic Therapy for Advanced Gastric Cancer (Drug)
Patients do not undergo surgery. They continue the original conversion regimen or an MDT-adjusted systemic therapy for a total of 8 cycles, followed by maintenance therapy for up to 1 year after randomization, or until disease progression, unacceptable toxicity, or withdrawal. Salvage surgery is permitted if clinically indicated.

Eligibility criteria

Inclusion Criteria: * Patients voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance. * Age ≥ 18 years and ≤ 70 years. * Histologically and/or cytologically confirmed gastric cancer. * No evidence of gastric outlet obstruction or intestinal obstruction. * No distant metastasis on imaging examination. Initial laparoscopic exploration confirms CY0P1 or CY1P1, without distant organ metastasis, with a recorded peritoneal carcinomatosis index (PCI) ≤ 20, and with either positive or negative ascites. Patients meeting these criteria are eligible for pre-enrollment. Following successful conversion therapy, a second laparoscopic exploration must confirm conversion to CY0P0, with no distant organ metastases and no regional lymph node metastases beyond the second station. Only upon meeting these criteria are patients formally enrolled in the study. * No prior chemotherapy, targeted therapy, or immunotherapy. * ECOG performance status score of 0-2. * Life expectancy ≥ 12 weeks. * Laboratory requirements: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 8 g/dL; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 1.5 × ULN. In the presence of liver metastases, AST and ALT ≤ 5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (CCr) ≥ 60 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. Exclusion Criteria: * Initial laparoscopic exploration reveals P0, or either of the two laparoscopic explorations reveals distant organ metastasis or distant lymph node metastasis. * Prior anticancer therapy, including chemotherapy, targeted therapy, or immunotherapy. * Hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg). * Active bleeding or coagulation disorder within 2 months prior to enrollment, bleeding tendency, or ongoing thrombolytic therapy, deemed by the investigator as unsuitable for enrollment. * Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris. Left ventricular ejection fraction (LVEF) \< 50% on echocardiography, or poorly controlled arrhythmia. * Known allergy to immunotherapy agents, chemotherapy agents, or any of their excipients. * Pregnancy (positive pregnancy test prior to treatment initiation) or breastfeeding. * Active or uncontrolled severe infection: Severe infection within 4 weeks prior to enrollment (e.g., requiring intravenous antibiotics, antifungals, or antivirals); Known human immunodeficiency virus (HIV) infection; History of clinically significant liver disease, including viral hepatitis. For known hepatitis B virus (HBV) carriers, active HBV infection must be excluded, defined as HBV DNA positive (\> 1 × 10⁴ copies/mL or \> 2000 IU/mL); Known hepatitis C virus (HCV) infection with positive HCV RNA (\> 1 × 10³ copies/mL), or other hepatitis, cirrhosis. * Urinalysis indicating proteinuria ≥ 2+, with 24-hour urine protein quantification \> 1.0 g. * Any other condition deemed by the investigator as inappropriate for participation in this study.

Conditions

Gastric Cancer Peritoneal Metastasis

Locations

Peking University Cancer Hospital — Beijing, Beijing Municipality, China
Chinese PLA General Hospital — Beijing, Beijing Municipality, China
Peking University International Hospital — Beijing, Beijing Municipality, China
The First Affiliated Hospital of Army Medical University — Chongqing, Chongqing Municipality, China
Zhangzhou Affiliated hospital of Fujian Medical University — Zhangzhou, Fujian, China
Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China
The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hubei, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School — Nanjing, Jiangsu, China
Jiangsu Cancer Hospital — Nanjing, Jiangsu, China
Jiangsu Province Hospital — Nanjing, Jiangsu, China
Nantong First People's Hospital — Nantong, Jiangsu, China
The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
ShangRao People's Hospital — Shangrao, Jiangxi, China
The First Hospital of Jilin University — Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China
The Second Affiliated Hospital of Airforce Military Medical University — Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China
The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China
Shandong Provincial Hospital — Jinan, Shandong, China
The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China
Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
Shanghai General Hospital — Shanghai, Shanghai Municipality, China
Changzhi People's Hospital — Changzhi, Shanxi, China
Tianjin Medical University Cancer Institute＆Hospital — Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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