Clinical trial · Observational
Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
Observational Prospective Cohort Study on Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Cancer
NCT07313579CI-TRIAL-00100704G-PECrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer (GC) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| HIPEC | — | UNRESOLVED | — |
| Hyperthermic Intraperitoneal Chemoperfusion | — | UNRESOLVED | — |
| Peritoneal Metastases From Gastric Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| curative-intent surgery + HIPEC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Prophylactic cohort (T4a/T4b/cyt+)
- description
- The cohort consists of individuals undergoing gastrectomy along with HIPEC.
- interventionNames
- Procedure: curative-intent surgery + HIPEC
- label
- Low PCI cohort (PCI<7)
- description
- Patients with low PCI undergo curative surgery with cytoreduction of visually detected peritoneal nodules followed by HIPEC
- interventionNames
- Procedure: curative-intent surgery + HIPEC
Primary outcomes (1)
- measure
- Peritoneal recurrence rate
- timeFrame
- From enrolment up to 5 years of follow-up
- description
- Number of patients developed peritoneal recurence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.