NCT06768463 Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer

Eligibility & Interventions

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This trial targets 250 participants in total. It began in 2025-08-01 with a primary completion date of 2027-07-10.

Brief Summary

The results of the current studies to determine the optimal strategy for metastatic gastric cancer remain contrversial worldwide. Hypothesis: Cytoreductive Gastrectomy After Systemic Therapy will improve survival time for metastasis gastric cancer compared to Systemic Therapy alone.

Eligibility Criteria

Inclusion criteria General criteria * Age 18-75 * GCLM detected on surgical exploration and demonstrated by histology or cytology * Localized peritoneal carcinomatosis (P1 or P2 score), according to the classification of the Japanese Research Society for Gastric Cancer * Liver metastasis lesions of maximum diameter ≤5 cm * Para-aortic lymph node metastasis below the coeliac axis or above the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter≥1cm) * Bilateral or unilateral Krukenberg tumors were allowed and considered 1 incurable organ site * The accepted patient has two metastases * Baseline Eastern Cooperative Oncology Group (ECOG) performance status \< 1 * Basic laboratory tests demonstrating adequate bone marrow function (neutrophil count \> 1500mm3, haemoglobin \> 8g/dL, platelet count \> 100,000/mm3), adequate liver function (bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within upper limits of normal), adequate renal function (serum creatinine within the upper limit of normal) * Expected survival \> 3 months * Able to tolerate enteral nutrition and adequate mental capacity to give informed consent * Completed 4 cycles of first-line standard-of systemic therapy * Repeat diagnostic laparoscopy after first-line treatment prior to randomization demonstrating feasible resection. Eligibility criteria for resection \& extent of proposed resection * Staging scans (cross-sectional imaging) demonstrating no extra metastases (lung, bone,...) * Cross-sectional imaging demonstrating no local progression of PM * PCI score \<12 * Cytology +ve alone (no gross PM) permissible for enrolment * Feasible R0 resection (reasonable chance of negative margins on histology) * Feasible D1, D1+ or D2 lymphadenectomy Exclusion criteria * Any extra-abdominal metastasis at diagnosis or during systemic treatment. * Past history of malignancy other than gastric cancer diagnosed in the last 5 years except for basal cell carcinoma of skin or preinvasive cancer of cervix * Patients in the reproductive age who declined to use an adequate means of contraception * Significant disease or conditions which, in the investigator's opinion, would exclude patient from the study * Uncontrolled concurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * Pregnant and lactating females * Prior surgical treatment for GC involving resection * Clinical or radiological progression during 1st line systemic treatment * Patients with radiological progression of LM (determined by RECIST criteria) to be excluded as disease is likely not responding well to 1st line treatment. * Patients with clinical progression of LM as defined by increasing ascites requiring intervention (ascitic tap/drain, hospital admission etc) or causing significant symptoms to the patient (tense distended abdomen, early satiety, shortness of breath etc). * Ascites volume as a reflection of disease control is difficult to assess and quantify or a reflection of disease progression. (15) * Any patient deemed unresectable or requiring extensive resection beyond procedure approved in the study protocol * PCI \> 12 * Extensive bowel / mesentery involvement requiring \>2 separate / non-contiguous small or large bowel resections in addition to the gastrectomy * Involvement of the head of pancreas or bile duct * PM or nodal disease in the hepatoduodenal ligament * Involvement of major vascular structures * Involvement of esophagus precluding a reasonable chance of R0 resection by transhiatal approach Withdrawal Criteria * Patient decides to withdraw from the study, or * The investigator concludes that it is in the patient's best interest to discontinue study treatment.

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