Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer (G-PEC)

Ukrainian Society of Clinical Oncology

Status: Enrolling

Conditions: Gastric Cancer (GC); HIPEC; Peritoneal Metastases From Gastric Cancer; Hyperthermic Intraperitoneal Chemoperfusion

Treatments: Procedure: curative-intent surgery + HIPEC

Study type: Observational

Funder types: Other

Identifiers

NCT07313579

24999/2025

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-80
2. Hystologicaly proven gastric adenocarcinoma
3. ECOG status 0-1
4. Written consent to participate in the study
5. Medically and technically operable gastric tumor
6. Only T4a or T4b tumours with any peritoneal cytology status
7. Cytologically positive peritoneal washings (cyt+) with any T and N criteria
8. Adequate haemopoetic, renal and hepatic function (Hb > 120, PLT > 150*10^9/l, ALT < 60, AST <40, total bilirubin < 21 µmol/l, Creatinine clearance (male - 90-140, female - 80-130 ml/min)

Exclusion criteria

1. Pregnancy/breastfeeding
2. ECOG status 2-4
3. Concomitant malignancy
4. Mitomycin and/or Cisplatin hypersensitivity
5. Uncontrollable chronic diseases
6. Patients with coexisting malignancy other than basal cell carcinoma of the skin within the last five years.
7. Presence of metastases other than regional or peritoneal (such as liver, lungs, bone, brain, distant lymph nodes)
8. History of allergic reactions associated with cisplatin and Mitomycin C
9. Patients with psychiatric illness/social situations with impaired compliance
10. •Refusal to participate

Trial design

200 participants in 2 patient groups

Prophylactic cohort (T4a/T4b/cyt+)

Description:

The cohort consists of individuals undergoing gastrectomy along with HIPEC.

Treatment:

Procedure: curative-intent surgery + HIPEC

Low PCI cohort (PCI<7)

Description:

Patients with low PCI undergo curative surgery with cytoreduction of visually detected peritoneal nodules followed by HIPEC

Treatment:

Procedure: curative-intent surgery + HIPEC