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Clinical trial Recruiting at 1 site Observational Ages 18 to 80

HIPEC during curative gastrectomy for advanced or low‑volume metastatic gastric cancer

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

Run by Ukrainian Society of Clinical Oncology · NCT07313579 · Data updated 2026-11-12

This tests whether adding a single heated dose of chemotherapy inside the abdomen (HIPEC) during curative gastrectomy helps people with T4 tumors or low‑volume peritoneal gastric cancer.

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment200 (estimated)
SponsorUkrainian Society of Clinical Oncology
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Kyiv)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 1, 2030
Study endsDecember 1, 2035
Registry record updatedJanuary 13, 2026
Trial IDNCT07313579 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 18–80 with histologically confirmed gastric adenocarcinoma who are medically and technically operable, have ECOG 0–1, and have T4 disease or positive peritoneal cytology or low PCI.

Probably not a fit

Patients with distant metastases outside the peritoneum, poor performance status (ECOG ≥2), pregnancy, or known hypersensitivity to cisplatin/mitomycin are unlikely to benefit or are excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study that follows patients who undergo curative‑intent gastrectomy followed by a single intraoperative dose of hyperthermic intraperitoneal chemotherapy (HIPEC). Eligible patients include those with T4a/T4b tumors, positive peritoneal cytology, or limited peritoneal disease. Investigators will collect outcomes including peritoneal recurrence, postoperative complications, and survival metrics over follow‑up. The protocol is non‑randomized and reports real‑world outcomes of combining surgery with intra‑abdominal heated chemotherapy.

Why it matters

Potential benefit: If successful, this approach could reduce peritoneal relapse after surgery and extend disease‑free survival for selected patients.

How similar studies have gone: Prior case series and some trials have shown promising reductions in peritoneal relapse with HIPEC in selected patients, but results are mixed and high‑quality randomized evidence remains limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • National Cancer Institute (NCI)
    Kyiv, Ukraine     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.