Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer

NCT ID: NCT07313579

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2035-12-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prophylactic cohort (T4a/T4b/cyt+)

The cohort consists of individuals undergoing gastrectomy along with HIPEC.

curative-intent surgery + HIPEC

Intervention Type 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)

Patients with low PCI undergo curative surgery with cytoreduction of visually detected peritoneal nodules followed by HIPEC

curative-intent surgery + HIPEC

Intervention Type 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

Interventions

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curative-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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ukrainian Society of Clinical Oncology

OTHER

Sponsor Role lead

Responsible Party

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Oleksii Dobrzhanskiy

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Institute (NCI)

Kyiv, , Ukraine

Site Status RECRUITING

Countries

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Ukraine

Central Contacts

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Oleksiy Dobrzhanskyi, MD

Role: CONTACT

+380638760185

Facility Contacts

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Oleksiy Dobrzhanskyi, MD

Role: primary

+380638760185

Oleksiy Dobrzhanskyi, MD

Role: backup

Other Identifiers

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24999/2025

Identifier Type: -

Identifier Source: org_study_id

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