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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)
EU CTIS ID: 2024-516194-76-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Gastric or GE junction Siewert type III adenocarcinomas (by pre-inclusion biopsy)
- Able and willing to provide written informed consent in site local language or English, and to comply with the clinical study protocol
- 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
- cT3-4a for any differentiation grade and histological subtype
- cT2 if poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells
- 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
You likely can't join if
- Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds
- Renal impairment, defined as GFR < 40 ml/min (Cockcroft-Gault Equation).
- Myocardial insufficiency, defined as NYHA class 3-4
- An impaired liver function, defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
- An inadequate haematological function, defined as ANC<1.5 x 109/l and platelets <100 x 109/l.
- Any other condition or therapy which, in the investigator’s opinion, may pose a risk to the patient or interfere with the study objectives
See the full eligibility criteria
- Gastric or GE junction Siewert type III adenocarcinomas (by pre-inclusion biopsy)
- Able and willing to provide written informed consent in site local language or English, and to comply with the clinical study protocol
- 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
- cT3-4a for any differentiation grade and histological subtype
- cT2 if poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells
- 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
- Any cN
- 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)
- Performance status ECOG 0-1
- Age 18 – 80 years
- Undergoing robotic or laparoscopic D2 gastrectomy
- Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds
- Renal impairment, defined as GFR < 40 ml/min (Cockcroft-Gault Equation).
- Myocardial insufficiency, defined as NYHA class 3-4
- An impaired liver function, defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
- An inadequate haematological function, defined as ANC<1.5 x 109/l and platelets <100 x 109/l.
- Any other condition or therapy which, in the investigator’s opinion, may pose a risk to the patient or interfere with the study objectives
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.