Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie rak otrzewnej pochodzący z jelita grubego, jelita cienkiego lub wysoko złośliwego raka wyrostka robaczkowego
- •Wiek 18 lat lub więcej
- •Ukończona co najmniej 4-miesięczna pierwsza linia chemioterapii układowej (oparta na fluorouracylu)
- •Dobry ogólny stan zdrowia (skala ECOG 0 lub 1)
- •Prawidłowe funkcje wątroby, nerek i szpiku kostnego (odpowiednie poziomy białych krwinek, płytek krwi i enzymów wątrobowych)
- •Choroba, którą nie można wyleczyć zwykłą chirurgią lub pacjent odmawia agresywnej operacji cytoredukcyjnej
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 16, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Moffitt Cancer Center
Tampa, United States
Trial contact
Valentina Diaz Aranzazu
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/17/2026.
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