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

RecruitingPhase 3Ages 18 Years - 70 YearsAllHua Huang, MD, PhD
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In plain words

What the trial is, and whether it could suit you

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 abse

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Radical Gastrectomy with D2 Lymphadenectomy
  • Standard Systemic Therapy for Advanced Gastric Cancer
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Where

31 sites
Peking University Cancer Hospital
Beijing, China
Chinese PLA General Hospital
Beijing, China
Peking University International Hospital
Beijing, China
The First Affiliated Hospital of Army Medical University
Chongqing, China
Zhangzhou Affiliated hospital of Fujian Medical University
Zhangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, China

…and 23 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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