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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
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.
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.
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
Overall Survival (OS)
Time frame: Up to 3 years after randomization
Quality of Life (QoL) assessed by EORTC QLQ-C30 questionnaires
Time frame: Prior to first-look laparoscopy, prior to second-look laparoscopy, 1-month post-randomization, 3-months post-randomization, then every 3-months thereafter up to 3-years after randomization
Quality of Life (QoL) assessed by EORTC QLQ-STO22 questionnaires
Time frame: Prior to first-look laparoscopy, prior to second-look laparoscopy, 1-month post-randomization, 3-months post-randomization, then every 3-months thereafter up to 3-years after randomization
Pathological Complete Response (pCR) Rate
Time frame: At the time of radical surgery
R0 Resection Rate
Time frame: At the time of radical surgery
Complication-Free Survival
Time frame: Up to 3 years after randomization
Major Complication Rate
Time frame: Within 30 days and 90 days after surgery
Progression-Free Survival (PFS) and Peritoneal PFS
Time frame: Up to 3 years after randomization
Time to Peritoneal Re-dissemination
Time frame: Up to 3 years after randomization
Length of Hospital Stay
Duration of postoperative hospital stay, calculated from the date of surgical intervention to the date of hospital discharge, only applicable to participants receiving surgical treatment.
Time frame: Perioperative period
Readmission Rate
Time frame: Within 30 days and 90 days post-surgery
Treatment Interruption Rate
Time frame: Within 1-year after randomization
Direct Medical Costs / Hospitalization Costs
Direct medical costs are defined as all medical expenses directly related to the patient's care, including hospitalization, surgery, medications, laboratory tests, imaging examinations, and management of complications. Data will be collected continuously throughout the study period (from baseline until death or study completion) and aggregated at the end of the study.
Time frame: Baseline through study completion, an average of 3-years post-randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 21 more locations