Clinical Trial

Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors

Not Yet Recruiting Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-17.
Trial Details
NCT Number NCT07487168
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Conditions Peritoneal Carcinomatosis
Enrollment 24 participants
Start Date 2026-08
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-05-15