Trials
Search / Trial NCT05644249

PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer

Launched by VILNIUS UNIVERSITY · Nov 30, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

Gastric Cancer Peritoneal Carcinomatosis Pipac Folfox Bidirectional

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with gastric cancer that has spread to the lining of the abdomen, known as peritoneal carcinomatosis. The study is looking at the combination of two treatments: a special type of chemotherapy called pressurized intraperitoneal aerosol chemotherapy (PIPAC) and a standard chemotherapy regimen called FOLFOX. PIPAC is designed to deliver the chemotherapy in a fine mist, which may help the medicine reach the cancer more effectively. The goal of this trial is to see how well these two treatments work together and if they are safe for patients with this type of cancer.

To participate in the trial, patients must be at least 18 years old and have a confirmed diagnosis of gastric adenocarcinoma that has spread to the peritoneum. They should not have cancer that has spread outside the abdomen or have certain other health issues. Participants will receive both PIPAC and FOLFOX chemotherapy and will be closely monitored throughout the treatment. This study is currently recruiting patients, and it offers an opportunity to try a potentially promising new approach for a challenging condition.

Gender

ALL

Eligibility 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

Trial Officials

Skaiste Tulyte, MD

Principal Investigator

Vilnius University Hospital Santaros Klinikos

About Vilnius University

Vilnius University, a leading academic institution in Lithuania, is dedicated to advancing medical research and enhancing healthcare outcomes through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses its extensive expertise in various medical fields to explore novel treatment modalities and improve patient care. Committed to ethical standards and rigorous scientific methodologies, Vilnius University strives to contribute valuable insights to the global medical community, fostering advancements that benefit both local and international populations.

Locations

Vilnius, , Lithuania

Vilnius, Vilniaus, Lithuania

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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