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RecruitingNCT07313579

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

Observational Prospective Cohort Study on Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

Status
Recruiting
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Ukrainian Society of Clinical Oncology · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The study investigates the outcomes of hyperthermic intraperitoneal chemoperfusion (HIPEC) in combination with curative-intent gastrectomy in resectable locally-advanced and limited-metastatic (low peritoneal cancer index) gastric cancer.

Detailed description

Several recent studies showed that near-perfect curative-intent R0 surgical technique combined with systemic chemotherapy or even immunotherapy may not always be enough to eliminate microscopic deposits or eliminate peritoneal dissemination in locally advanced gastric cancer or low peritoneal cancer-index (PCI) tumors. The risk of peritoneal dissemination is especially high for T4 tumors, for those with cytologically positive peritoneal washings. Moreover, the risk of peritoneal relapse in low PCI tumors is remarkably high. Combination of surgery and intraperitoneal chemotherapy aims to minimise the risks of the aforementioned peritoneal progression. In the study investigators perform curative surgery followed by single dose of hyperthermic intraperitoneal chemotherapy (HIPEC).

Conditions

Interventions

TypeNameDescription
PROCEDUREcurative-intent surgery + HIPECParticipants enrolled in this study will undergo curative-intent gastrectomy for gastric cancer, immediately followed by Hyperthermic Intraperitoneal Chemotherapy (HIPEC) performed during the same operative session. Dosage of drugs: mitomycin C 15 mg/m2, cisplatin 75mg/m2. The procedure is conducted according to a standardized protocol in National Cancer Institute

Timeline

Start date
2025-12-01
Primary completion
2030-12-01
Completion
2035-12-01
First posted
2026-01-02
Last updated
2026-01-13

Locations

1 site across 1 country: Ukraine

Source: ClinicalTrials.gov record NCT07313579. Inclusion in this directory is not an endorsement.