HIPEC during curative gastrectomy for advanced or low‑volume metastatic gastric cancer
Observational Prospective Cohort Study on Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
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 type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ukrainian Society of Clinical Oncology Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Kyiv) |
| Trial ID | NCT07313579 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kyiv
- National Cancer Institute (NCI) — Kyiv, Ukraine (Recruiting)
Study contacts
- Study coordinator: Oleksiy Dobrzhanskyi, MD
- Email: alekseydobrzhanskiy@gmail.com
- Phone: +380638760185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.