Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

PIPAC with Mitomycin C for unresectable peritoneal cancer

Official title: 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

Run by H. Lee Moffitt Cancer Center and Research Institute · NCT07487168 · Data updated 2026-11-12

This phase 1 study tests a breathy, pressurized chemotherapy method (PIPAC-MMC) to see if it is safe and tolerable for adults with unresectable peritoneal carcinomatosis from colorectal, appendiceal, or small bowel cancers.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment24 (estimated)
SponsorH. Lee Moffitt Cancer Center and Research Institute
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Tampa, Florida)
StatusRecruiting
StartedAugust 5, 2026
Main results expectedMarch 2028
Study endsMarch 2028
Registry record updatedSeptember 16, 2026
Trial IDNCT07487168 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with histologically confirmed peritoneal carcinomatosis from colorectal, small bowel, or high-grade appendiceal adenocarcinoma who are ineligible for CRS/HIPEC and have completed at least 4 months of first-line therapy.

Probably not a fit

Patients whose disease progresses rapidly or who cannot tolerate intraperitoneal chemotherapy may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, phase 1 dose-escalation trial uses a Bayesian design to determine the safe dose of mitomycin C delivered as pressurized intraperitoneal aerosol chemotherapy (PIPAC) in patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries. Up to three PIPAC procedures are given at 8-week intervals, with continuation of 5-FU/LV between procedures. The study will assess safety, tolerability, and determine the recommended phase 2 dose, while also collecting pharmacokinetic and pharmacodynamic data and quality of life measures. Participants must have histologically confirmed peritoneal disease and be ineligible for cytoreductive surgery with HIPEC, be at least 18 years old, and have completed at least 4 months of first-line systemic therapy. Primary site is Moffitt Cancer Center in Tampa, FL, under the lead sponsorship of H. Lee Moffitt Cancer Center.

Why it matters

Potential benefit: If successful, the approach could provide a new treatment option that potentially slows disease and improves symptom control for patients with unresectable peritoneal carcinomatosis.

How similar studies have gone: Prior studies of PIPAC have shown manageable safety with signals of disease control in similar peritoneal malignancies, though this exact mitomycin C dosing in a BOIN-driven phase 1 is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Participants must have histologically confirmed peritoneal disease from colorectal, small bowel, or high grade appendiceal adenocarcinoma. High grade appendiceal cancers include moderate or poorly differentiated mucinous or non-mucinous adenocarcinoma, signet ring cell adenocarcinoma, or goblet cell adenocarcinoma. This can be established by image guided biopsy, diagnostic laparoscopy, or previous surgery.
* Patients must be ineligible for CRS/HIPEC through one of the following criteria: a) PCI score ≥16. b) Inability to achieve complete cytoreduction due to extent of disease. c) Significant small bowel involvement precluding a complete CRS. d) Unresectable disease in porta hepatis, pelvic side wall or other critical structure. e) Patients who decline invasive cytoreduction.
* Participants must be 18 years of age or older.
* Participants must have completed at least 4 months of first-line systemic therapy (5-FU based approach with or without biologic therapy).
* Participants must have Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
* Participants must have adequate organ and marrow function as defined below: a) absolute neutrophil count ≥1500/mcL. b) platelets ≥100,000/mcL. c) total bilirubin ≤ institutional upper limit of normal (ULN). d) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN. e) creatinine ≤ 1.5 institutional ULN. or f) glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2.
* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should undergo a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification (see Appendix C).

To be eligible for this trial, participants should be class 2B or better.

* MMC is a known teratogen, for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration. For women of child-bearing potential a negative urine pregnancy test is required on the morning of surgery.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants who have received targeted therapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks for VEGF inhibitors, nitrosoureas or mitomycin C) prior to entering the study.
* Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1), except for alopecia and chemotherapy induced peripheral neuropathy \< 2.
* Patients with extensive metastatic liver disease (\>50% liver volume) are excluded from the trial as are patients with brain metastases. Patients with non-peritoneal metastatic disease are otherwise eligible provided they meet the survival expectations of \>6 months.
* Patients with brain metastases are excluded
* Patients with bowel obstruction or need for nutritional support (i.e., TPN or tube feeds).
* Participants who are receiving any other investigational agents or enrolled on other research protocols that may interfere with compliance with requirements of the study.
* History of allergic reactions or poor tolerance attributed to compounds of similar chemical or biologic composition to MMC, fluoropyrimidines, or anesthesia medications.
* Participants with uncontrolled intercurrent illnesses.
* Participants with psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because MMC is an antibiotic alkylating antineoplastic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MMC, breastfeeding should be discontinued if the mother is treated with MMC.
* Inability to safely perform laparoscopy due to previously noted adhesions or extensive prior surgery which the treating surgeon feels would exclude safe abdominal access.
* Life expectancy less than 6 months.
* Patients with history of thromboembolic complications that cannot discontinue for the perioperative duration.

Where it's running

  • Moffitt Cancer Center
    Tampa, Florida, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.