Radical Surgery vs Non-Surgery in Gastric Cancer with Peritoneal Metastasis after Successful Conversion Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares radical gastrectomy with standard systemic therapy in patients who achieved conversion therapy for gastric cancer with peritoneal metastasis. Eligible participants undergo initial laparoscopic assessment, receive conversion therapy, and, if criteria are met, are randomized to radical gastrectomy with D2 lymphadenectomy or continued non-surgical systemic treatment. The study aims to determine if surgery improves overall survival and quality of life compared with ongoing non-surgical treatment, while monitoring safety. Enrollment is limited to adults up to age 70 with controlled disease and no distant metastasis after conversion.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking University International Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• The First Affiliated Hospital of Army Medical University
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Zhangzhou Affiliated hospital of Fujian Medical University
  Zhangzhou, Fujian, China Not yet recruiting

Study contacts

• Study coordinator: Hua Huang
• Email: huahuang@fudan.edu.cn
• Phone: +86-13816151816

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.