Gastric Cancer, Peritoneal Metastasis
Conditions
Brief summary
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
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.
DRUGStandard Systemic Therapy for Advanced Gastric Cancer
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.
Sponsors
Hua Huang, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to 3 years after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication-Free Survival | Up to 3 years after randomization | — |
| Major Complication Rate | Within 30 days and 90 days after surgery | — |
| Progression-Free Survival (PFS) and Peritoneal PFS | Up to 3 years after randomization | — |
| Time to Peritoneal Re-dissemination | Up to 3 years after randomization | — |
| Length of Hospital Stay | Perioperative period | 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. |
| R0 Resection Rate | At the time of radical surgery | — |
| Treatment Interruption Rate | Within 1-year after randomization | — |
| Direct Medical Costs / Hospitalization Costs | Baseline through study completion, an average of 3-years post-randomization | 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. |
| Quality of Life (QoL) assessed by EORTC QLQ-C30 questionnaires | 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 | 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 | At the time of radical surgery | — |
| Readmission Rate | Within 30 days and 90 days post-surgery | — |
Countries
China
Contacts
CONTACTHua Huang
Outcome results
None listed