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
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.
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.
Parallel
Radical Gastrectomy with D2 Lymphadenectomy
Procedure/SurgeryPatients 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
DrugPatients 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.
Overall Survival (OS)
Quality of Life (QoL) assessed by EORTC QLQ-C30 questionnaires
Quality of Life (QoL) assessed by EORTC QLQ-STO22 questionnaires
Pathological Complete Response (pCR) Rate
R0 Resection Rate
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Hua Huang, MD, PhD
Lead sponsor
Shanghai Cancer Hospital, China
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
