Clinical trial · Interventional
The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.
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
NCT06295094CI-TRIAL-00074762EPICUREnot yet recruitingPhase 2ClinicalTrials.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 goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal 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 when compared to standard treatment.
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 |
|---|---|---|---|
| Chemotherapy, Adjuvant | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Minimally Invasive Surgical Procedures | — | UNRESOLVED | — |
| Peritoneal Metastases | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pressurized intraperitoneal chemotherapy (PIPAC)
- description
- In the intervention arm, conventional pressurized intraperitoneal chemotherapy (PIPAC) with cisplatin (10.5 mg/m2 body surface in 150ml saline) and doxorubicin (2.1 mg/m2 body surface in 50ml saline) is performed through Medical Device Regulation (MDR) class IIb the CE-certified nebuliser by certified PIPAC surgeons directly after the completion of the minimally invasive gastric resection and reconstruction using the remaining relevant ports. Chemotherapy is administered through a CE-certified nebulizer according to the manufacturer's manual and followed by 30 minutes of simple diffusion. The carbondioxide is evacuated through a closed system, and the abdominal wall is closed according to local surgical standards. The same procedure is repeated, incorporating the same compounds and dose regimens six to eight weeks postoperatively and before the start of the adjuvant part of the perioperative systemic chemotherapy.
- interventionNames
- Drug: Cisplatin
- Drug: Doxorubicin
- type
- NO_INTERVENTION
- label
- Standard
- description
- In the control arm, patients will undergo minimally invasive D2 gastrectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria * Gastric or Gastroesophageal junction Siewert type III adenocarcinomas * Clinical T3-4a-stages 1. Any differentiation grade 2. Any histological subtype * Clinical T2-stage a. If poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells * Any clinical T-stage with positivity for malignant cells on abdominal lavage cytology, which is converted to cytology negative in response to neoadjuvant chemotherapy. * Any clinical nodal-stage * clinical M0-stage (positive abdominal wash cytology, which is converted to cytology negative in response to neoadjuvant therapy, is permitted) * Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 * Age 18 - 80 years * Undergoing robotic or laparoscopic D2 gastrectomy * Able and willing to provide written informed consent 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. Exclusion criteria * Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds. * Renal impairment, defined as glomerular filtration rate (GFR) \< 40 ml/min (Cockcroft-Gault Equation). * Myocardial insufficiency, defined as New York Heart Association (NYHA) class 3-4. * An impaired liver function, defined as bilirubin ≥ 1.5 x upper normal limit (UNL). * An inadequate haematological function, defined as absolute neutrophil count (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.
References
Publications (0)
Data not yet available
No reference posted for this study.