RecruitingNot ApplicableNCT06768463

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

Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer: An Open-label Randomized Controll Trial

Sponsor

University Medical Center Ho Chi Minh City (UMC)

Enrollment

250 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Metastatic Gastric Cancer Systemic Therapy Cytoreductive Gastrectomy

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria20

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 Criteria21

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.