drugset / Trial / NCT05644249

PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer

NCT05644249

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2022-12-01
Primary completion
2025-06-01
Completion
2025-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 10.5 mg/m2 Other
Subject Doxorubicin Other / unclassified 2.1 mg/m2 Other
Subject Leucovorin Small molecule
Subject Oxaliplatin Small molecule
Subject fluorouracil Small molecule