Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors
NCT: NCT07487168 · NOT_YET_RECRUITING
Brief Summary
This single-center, Phase 1 dose-escalation study will evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of pressurized intraperitoneal aerosol chemotherapy with mitomycin C (PIPAC-MMC) for patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries (colorectal, high-grade appendiceal, or small bowel). Up to three PIPAC procedures are planned at 8-week intervals while patients continue 5-fluorouracil/leucovorin (5-FU/LV) between procedures. The trial uses a Bayesian optimal interval (BOIN) design to determine dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD). Pharmacokinetics (PK), pharmacodynamics (PD), and quality of life (QoL) will be assessed.
Frequently Asked Questions
What is Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors?
Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors is a clinical trial registered under NCT07487168. Current status: NOT_YET_RECRUITING.
What is the status of NCT07487168?
The current status of NCT07487168 (Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors) is: NOT_YET_RECRUITING.
When did Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors start?
Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors started on 2026-08.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.