Recruiting
Phase 2

HIPEC vs. PIPAC

Sponsor:

Patrick Wagner, MD, FACS

Code:

NCT07282834

Conditions

Peritoneal (Metastatic) Cancer

Peritoneal Carcinomatosis

Abdominal Cancer

Abdominal Cancer Patients

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Heated intra-peritoneal chemotherapy

Aerosolized intra-peritoneal chemotherapy

Study Details

Brief summary:

This research study aims to improve the treatment of Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen. Patients with PC often experience significant pain and nutritional problems. Currently, there isn't a standard treatment approach, and doctors use different combinations of chemotherapy, surgery, and methods to deliver chemotherapy directly into the abdomen (intra-peritoneal or "IP" chemotherapy).

The study will compare two IP chemotherapy methods: HIPEC and PIPAC. HIPEC involves circulating heated chemotherapy through the abdomen during surgery, while PIPAC delivers chemotherapy as a pressurized aerosol during a laparoscopic procedure. Both methods aim to achieve the same goal, but they haven't been directly compared to see which is safer, more tolerable, more effective, and provides better value.

Conditions

Peritoneal (Metastatic) Cancer

Peritoneal Carcinomatosis

Abdominal Cancer

Abdominal Cancer Patients

Study ID

NCT07282834

Start date

Jan 5, 2026

Status verified date

Feb, 2026

Completion date

Nov, 2040

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males or females age 18 to 80 years.
2. Biopsy-proven or clinically suspected peritoneal carcinomatosis
3. Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization
4. Not a candidate for surgical cytoreduction at the time of laparoscopy
5. Women at least 18 years of age of childbearing potential must have a negative urine/serum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
6. Must be able to read and understand English and consent for themselves

Exclusion Criteria:

1. Patients who are eligible for definitive cytoreductive surgery at the time of enrollment
2. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:

AST/SGOT > 2.5 times the upper limit of normal ALT/SGPT > 2.5 times the upper limit of normal Total bilirubin > 2.5 times the upper limit of normal Hemoglobin < 7 gm/dL White blood cell count < 3,000/ mm3 Platelet count < 50,000/mm3
3. Any investigational drug use within 30 days prior to enrollment.
4. Systemic therapy within 14 days prior to randomization
5. Allergy or medical contra-indication to chemotherapy utilized in this study
6. Medical contraindication to laparoscopic surgery or complex cytoreductive surgery
7. Pregnant or lactating females.
8. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Heated Intra-Peritoneal Chemotherapy (HIPEC) Administration of Mitomycin C Chemotherapy

Laparoscopic intraperitoneal administration of mitomycin C chemotherapy through peritoneal catheters, heated intra-peritoneal chemotherapy (HIPEC) delivered during surgical procedures.

active comparator: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Administration of Mitomycin C Chemotherapy

Conventional administration of pressurized/aerosolized laparoscopic delivery of mitomycin C chemotherapy (PIPAC)

Interventions

Heated intra-peritoneal chemotherapy

Mitomyocin C 40 mg will be administered in divided doses (30mg at time zero and 10mg at 60 minutes) for a total of 90 minutes at 41-43 degrees Celsius. Laparoscopic HIPEC will then be repeated laparoscopically up to two more times at 45 +/- 15 day intervals until three doses have been completed.

Aerosolized intra-peritoneal chemotherapy

PIPAC will be performed with mitomycin C, 12.5mg/m2, delivered laparoscopically for 30 minutes at ambient temperature. Laparoscopic PIPAC or be repeated laparoscopically up to two more times at 45 +/- 15 day intervals until three doses have been completed.

Primary outcome measure

  • Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events [ Time Frame: 150 days from Day #1 visit ]
  • Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications [ Time Frame: 150 days from Day #1 visit ]
  • Heated intra-peritoneal chemotherapy (HIPEC) Adverse Events [ Time Frame: 150 days from Day #1 visit ]
  • Heated intra-peritoneal chemotherapy (HIPEC) Surgical Complications [ Time Frame: 150 days from Day #1 visit ]
  • Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events [ Time Frame: 150 days from Day #1 visit ]
  • Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Adverse Events [ Time Frame: 150 days from Day #1 visit ]
  • Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications [ Time Frame: 150 days from Day #1 visit ]
  • Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Surgical Complications [ Time Frame: 150 days from Day #1 visit ]
  • Heated intra-peritoneal chemotherapy (HIPEC) Tolerability [ Time Frame: 150 days from Day #1 visit ]
  • Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability [ Time Frame: 150 days from Day #1 visit ]
  • Heated intra-peritoneal chemotherapy (HIPEC) Tolerability [ Time Frame: 150 days from Day #1 visit ]
  • Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability [ Time Frame: 150 days from Day #1 visit ]
  • Heated intra-peritoneal chemotherapy (HIPEC) Tolerability [ Time Frame: 150 days from Day #1 visit ]
  • Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Tolerability [ Time Frame: 150 days from Day #1 visit ]

Central Contacts and Locations

Central contacts

AHN Clinical Trial Contact Clinical Trial Contact

412-359-3731clinicaltrials@ahn.org

Locations

Allegheny Health Network West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

AHN Clinical Trial Contact Clinical Trial Contact

412-359-3731clinicaltrials@ahn.org

Principal Investigator:

Patrick Wagner, MD

More Information

Sponsor

Patrick Wagner, MD, FACS

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • intraperitoneal
  • peritoneal cavity
  • mitomycin-C
  • PIPAC
  • HIPEC
  • Heated Intra-Peritoneal Chemotherapy
  • Pressurized Intraperitoneal Aerosol Chemotherapy
  • intra-abdominal
  • cytoreduction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Patrick Wagner, MD, FACS on 2026-02-27.