Combination of PIPAC and FOLFOX for treating gastric cancer with peritoneal metastases
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
This study is testing a new way to treat gastric cancer that has spread in the abdomen by combining a special type of aerosol chemotherapy with standard chemotherapy to see if it works better for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vilnius University Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 2 sites (Vilnius, Vilniaus and 1 other locations) |
| Trial ID | NCT05644249 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of combining pressurized intraperitoneal aerosol chemotherapy (PIPAC) with systemic FOLFOX chemotherapy for patients with gastric cancer and peritoneal carcinomatosis. The approach aims to enhance drug distribution and penetration by using aerosolized chemotherapy under increased pressure. A total of 37 participants will receive three cycles of systemic chemotherapy followed by PIPAC treatments, with evaluations conducted after the third PIPAC procedure to determine further treatment options. The study is open-label and will take place at two major cancer treatment centers in Lithuania.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically verified HER2 negative gastric adenocarcinoma and peritoneal carcinomatosis who are eligible for first-line FOLFOX chemotherapy.
Not a fit: Patients with extra-abdominal metastases, certain types of gastroesophageal junction cancer, or those with mechanical bowel obstruction will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with gastric cancer and peritoneal metastases by enhancing drug delivery and efficacy.
How similar studies have performed: While PIPAC has shown encouraging preliminary results, the combination with systemic chemotherapy is still investigational and has limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis; 2. Age≥18; 3. ECOG≤1; 4. Patient willing to participate; 5. Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy. Exclusion Criteria: 1. Extra-abdominal metastases; 2. Siewert I type gastroesophageal junction cancer; 3. Mechanical bowel obstruction; 4. Allergy to study drugs; 5. History of previous intraperitoneal chemotherapy; 6. Pregnancy of refusal for birth-control at least 6 months post-study treatment
Where this trial is running
Vilnius, Vilniaus and 1 other locations
- Nationa Cancer Institute — Vilnius, Vilniaus, Lithuania (Recruiting)
- Vilnius University hospital Santaros Klinikos — Vilnius, Vilniaus, Lithuania (Recruiting)
Study contacts
- Principal investigator: Skaiste Tulyte, MD — Vilnius University Hospital Santaros Klinikos
- Study coordinator: Martynas Lukšta, MD
- Email: lukstamartynas@gmail.com
- Phone: +37064639565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.