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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]

Trial duration

28 May 2026 → ongoing

Decision date (initial)

2025-06-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

The Danish Cancer Society

External identifiers

EU CT number

2024-516194-76-00

ClinicalTrials.gov

NCT06295094

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis

The primary aim is to investigate whether pressurized intraperitoneal aerosol chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal-disease-free survival in patients with high-risk gastric adenocarcinoma.

Secondary objectives 9

1. Disease-free survival (DFS) with at least 12 months of follow-up (through electronic patient records up to five years after surgery)
2. Overall survival with at least 12 months of follow-up (through electronic patient records up to five years after surgery)
3. Length of stay (LOS) (Surgery = Day 0)
4. 30 days postoperative toxicity (CTCAE)
5. 30 days postoperative complications (Dindo-Clavien)
6. 90 days mortality
7. Rate of positive peritoneal lavage
8. Quality of life (EORTC QLQ-C30 + QLC-STO22)
9. The rate of included patients not receiving adjuvant chemotherapy as planned due to PIPAC-related complications

Conditions and MedDRA coding

Gastric adenocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Gastric or GE junction Siewert type III adenocarcinomas (by pre-inclusion biopsy)
2. cT3-4a for any differentiation grade and histological subtype
3. cT2 if poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells
4. Any cT with positivity for malignant cells on abdominal lavage cytology at pre-inclusion diagnostic laparoscopy, which is converted to cytology negative at separate laparoscopy in response to neoadjuvant chemotherapy
5. Any cN
6. cM0 (positive abdominal wash cytology at pre-inclusion diagnostic laparoscopy, which is converted to cytology negative at separate laparoscopy in response to neoadjuvant therapy, is permitted)
7. Performance status ECOG 0-1
8. Age 18 – 80 years
9. Undergoing robotic or laparoscopic D2 gastrectomy
10. Able and willing to provide written informed consent in site local language or English, and to comply with the clinical study protocol
11. Fertile women must have a negative pregnancy test at the time of inclusion and must use adequate contraception at inclusion and until at least three months after

Exclusion criteria 6

1. Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds
2. Renal impairment, defined as GFR < 40 ml/min (Cockcroft-Gault Equation).
3. Myocardial insufficiency, defined as NYHA class 3-4
4. An impaired liver function, defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
5. An inadequate haematological function, defined as ANC<1.5 x 109/l and platelets <100 x 109/l.
6. Any other condition or therapy which, in the investigator’s opinion, may pose a risk to the patient or interfere with the study objectives

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 9

1. Disease-free survival (DFS) with at least 12 months of follow-up (through electronic patient records up to five years after surgery)
2. Overall survival with at least 12 months of follow-up (through electronic patient records up to five years after surgery)
3. Length of stay (LOS) (Surgery = Day 0)
4. 30 days postoperative toxicity (CTCAE)
5. 30 days postoperative complications (Dindo-Clavien)
6. 90 days mortality
7. Rate of positive peritoneal lavage
8. Quality of life (EORTC QLQ-C30 + QLC-STO22)
9. The rate of included patients not receiving adjuvant chemotherapy as planned due to PIPAC-related complications

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J B Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

Jonas Sanberg

Public contact point

Organisation

Odense University Hospital

Contact name

Jonas Sanberg

Third parties 1

Locations

3 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications