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

January 10, 2026 updated by: Oleksii Dobrzhanskiy, Ukrainian Society of Clinical Oncology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult patients receiving care at oncological centers in Ukraine who meet all predefined eligibility criteria for this study. Investigators include individuals with for which Gastrectomy+HIPEC is considered an accepted or potentially beneficial treatment option according to national and international clinical guidelines. Participants will be recruited from tertiary surgical oncology hospitals and specialized cancer institutes across Ukraine.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prophylactic cohort (T4a/T4b/cyt+)
The cohort consists of individuals undergoing gastrectomy along with HIPEC.
Procedure: curative-intent surgery + HIPEC
Participants 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
Low PCI cohort (PCI<7)
Patients with low PCI undergo curative surgery with cytoreduction of visually detected peritoneal nodules followed by HIPEC
Procedure: curative-intent surgery + HIPEC
Participants 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peritoneal recurrence rate
Time Frame: From enrolment up to 5 years of follow-up
Number of patients developed peritoneal recurence
From enrolment up to 5 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant recurrence rate
Time Frame: Time from diagnosis up to 5 years of follow-up
Time from diagnosis to distant reccurence
Time from diagnosis up to 5 years of follow-up
Intraperitoneal chemotherapy complications rate
Time Frame: 30 days after chemotherapy
Complications rate assessed by Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Grade from 1 to 5)
30 days after chemotherapy
Postoperative complications rate
Time Frame: 30 days after surgery
Complications rate assessed by Clavien-Dindo scale (Grade from 1 to 5)
30 days after surgery
5-years overall survival
Time Frame: From the time of diagnosis up to 5 years of follow-up
5-years overall survival
From the time of diagnosis up to 5 years of follow-up
5-years relapse-free survival rate
Time Frame: Time from diagnosis up to 5 years of follow-up
5-years relapse-free survival rate
Time from diagnosis up to 5 years of follow-up
Treatment-related quality of life assessed by Quality Of Life Questionnaire C30 version 3.0
Time Frame: 6 months after treatment completion
Treatment-related quality of life assessed by Quality Of Life Questionnaire C30 version 3.0 (lower score means better outcomes, higher score means worse outcomes)
6 months after treatment completion
Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach
Time Frame: 6 months after treatment completion
Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (lower score means better outcomes, higher score means worse outcomes)
6 months after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ukrainian Society of Clinical Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24999/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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