The Efficacy of Pressurised Intraperitoneal aerosol chemotherapy (PIPAC) combined with CURativE intent minimally invasive radical resection in high-risk gastric cancer patients. A multicentre, randomised, open-label phase-II study (EPICURE, PIPAC-OPC6)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516194-76-00

Enrollment

123

Registered

2025-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric adenocarcinoma

Brief summary

Peritoneal disease-free survival (P-DFS) defined as no signs of peritoneal recurrence on PET-CT/CT and diagnostic laparoscopy with at least 12 months follow-up after minimally invasive D2-gastrectomy

Detailed description

Disease-free survival (DFS) with at least 12 months of follow-up (through electronic patient records up to five years after surgery), Overall survival with at least 12 months of follow-up (through electronic patient records up to five years after surgery), Length of stay (LOS) (Surgery = Day 0), 30 days postoperative toxicity (CTCAE), 30 days postoperative complications (Dindo-Clavien), 90 days mortality, Rate of positive peritoneal lavage, Quality of life (EORTC QLQ-C30 + QLC-STO22), The rate of included patients not receiving adjuvant chemotherapy as planned due to PIPAC-related complications

Interventions

DRUGDOXORUBICIN

DRUGCISPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Peritoneal disease-free survival (P-DFS) defined as no signs of peritoneal recurrence on PET-CT/CT and diagnostic laparoscopy with at least 12 months follow-up after minimally invasive D2-gastrectomy	—

Secondary

Measure	Time frame
Disease-free survival (DFS) with at least 12 months of follow-up (through electronic patient records up to five years after surgery), Overall survival with at least 12 months of follow-up (through electronic patient records up to five years after surgery), Length of stay (LOS) (Surgery = Day 0), 30 days postoperative toxicity (CTCAE), 30 days postoperative complications (Dindo-Clavien), 90 days mortality, Rate of positive peritoneal lavage, Quality of life (EORTC QLQ-C30 + QLC-STO22), The rate of included patients not receiving adjuvant chemotherapy as planned due to PIPAC-related complications	—

Measure

Time frame

—

Countries

Denmark, France, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026