NCT05644249Completed
PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Systemic Chemotherapy as a First-line Treatment for Gastric Cancer Peritoneal Metastases: Open-label, Single-arm, Multi-center Feasibility Study
Source: ClinicalTrials.gov · Last updated 24 Sept 2025
Brief summary (registry, in English)
Peritoneum is among the most common sites of metastases in gastric cancer. Systemic chemotherapy is the current standard for peritoneal carcinomatosis (PC), although, the treatment results remain extremely poor. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a modern treatment modality for PC, that 1) optimize the drug distribution by applying an aerosol rather than a liquid solution; and 2) apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target. Despite some encouraging preliminary results for PIPAC efficacy, it is still an investigational treatment. Furthermore, only very limited data exist for bidirectional treatment, which includes a combination of systemic chemotherapy and PIPAC. Thus, this study will investigate the feasibility of PIPAC and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 29 Sept 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Vilnius University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05644249
What you commit to
- Study type: Interventional
- Participants enrolled: 37
- From 1 Dec 2022 to the primary completion date, 1 Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous intraperitoneal chemotherapy;
Other illness
- Siewert I type gastroesophageal junction cancer;
- Allergy to study drugs;
Other
- Extra-abdominal metastases;
- Mechanical bowel obstruction;
- Pregnancy of refusal for birth-control at least 6 months post-study treatment
Who the study is looking for
- Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis;
- Age≥18;
- ECOG≤1;
- Patient willing to participate;
- Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vilnius University Hospital Santaros Klinikos Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
| Nationa Cancer Institute Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.