RecruitingNCT07313579

Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

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


Sponsor

Ukrainian Society of Clinical Oncology

Enrollment

200 participants

Start Date

Dec 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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 Criteria10

  • 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

Interventions

PROCEDUREcurative-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


Locations(1)

National Cancer Institute (NCI)

Kyiv, Ukraine

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NCT07313579


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