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NCT Number: NCT07313579

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80
  • Hystologicaly proven gastric adenocarcinoma
  • ECOG status 0-1
  • Written consent to participate in the study
  • Medically and technically operable gastric tumor
  • Only T4a or T4b tumours with any peritoneal cytology status
  • Cytologically positive peritoneal washings (cyt+) with any T and N criteria
  • 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

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

Treatment and study plan

curative-intent surgery + HIPEC

Procedure

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

Primary outcomes

  1. Peritoneal recurrence rate

    Time frame: From enrolment up to 5 years of follow-up

    Number of patients developed peritoneal recurence

Secondary outcomes

  1. Distant recurrence rate

    Time frame: Time from diagnosis up to 5 years of follow-up

    Time from diagnosis to distant reccurence

  2. 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)

  3. Postoperative complications rate

    Time frame: 30 days after surgery

    Complications rate assessed by Clavien-Dindo scale (Grade from 1 to 5)

  4. 5-years overall survival

    Time frame: From the time of diagnosis up to 5 years of follow-up

    5-years overall survival

  5. 5-years relapse-free survival rate

    Time frame: Time from diagnosis up to 5 years of follow-up

    5-years relapse-free survival rate

  6. 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)

  7. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Oleksiy Dobrzhanskyi, MD

CONTACT

[email protected]

+380638760185

Sponsors and collaborators

Lead sponsor

Ukrainian Society of Clinical Oncology

Other

Registry information

Official study title

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

Acronym: G-PEC

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Jan 2, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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