Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

NCT07313579 | Recruiting DMC

• 1 other identifier: 24999/2025
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer (GC); HIPEC; Peritoneal Metastases From Gastric Cancer; Hyperthermic Intraperitoneal Chemoperfusion

Keywords

Gastric cancer; HIPEC; Hyperthermic Intraperitoneal Chemoperfusion; FLOT; Lymphadenectomy; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Chemotherapy, Adjuvant; Combined Modality Therapy; Drug Therapy; Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Peritoneal recurrence rate

  Number of patients developed peritoneal recurence

  From enrolment up to 5 years of follow-up

Secondary Outcomes (7)

• Distant recurrence rate

  Time from diagnosis up to 5 years of follow-up

• Intraperitoneal chemotherapy complications rate

  30 days after chemotherapy

• Postoperative complications rate

  30 days after surgery

• 5-years overall survival

  From the time of diagnosis up to 5 years of follow-up

• 5-years relapse-free survival rate

  Time from diagnosis up to 5 years of follow-up

Study Arms (2)

Prophylactic cohort (T4a/T4b/cyt+)

The cohort consists of individuals undergoing gastrectomy along with HIPEC.

Procedure: curative-intent surgery + HIPEC

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

Interventions

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

Low PCI cohort (PCI<7); Prophylactic cohort (T4a/T4b/cyt+)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ukrainian Society of Clinical Oncology: lead

Study Sites (1)

National Cancer Institute (NCI)

Kyiv, Ukraine

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Central Study Contacts

Oleksiy Dobrzhanskyi, MD

CONTACT

+380638760185; alekseydobrzhanskiy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 2, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2035
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

UA (1)