NCT07487168

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

Phase 1 Single Center Study to Evaluate Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Single Agent Mitomycin C (MMC) in Peritoneal Carcinomatosis (PC) From Solid Gastrointestinal Malignancies (sGI-PC) in Palliative Setting

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peritoneal Carcinomatosis

Interventions

Type	Name	Description
DRUG	Mitomycin C (MMC)	Delivered intraperitoneally as aerosol under laparoscopy.
DEVICE	Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC)	A drug delivery approach in which the antineoplastic agent is delivered directly into the peritoneal cavity solution under laparoscopic pressures (12 mm HG).

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study