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NOT YET RECRUITING
NCT07856914
PHASE2

Paricalcitol Versus Pirfenidone for Improving Surgical Resectability in Patients With Peritoneal Cancer

Sponsor: Patrick Wagner, MD, FACS

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if paricalcitol or pirfenidone can help make tumors removable by surgery in adults with peritoneal cancer who are currently unable to have their tumor removed. The study aims to answer are whether paricalcitol or pirfenidone improve tumor response and tissue healing after 12 weeks of treatment, and which of these two drugs is more effective at helping participants become eligible for surgery. Researchers will compare paricalcitol to pirfenidone to see which drug works better and has a manageable safety profile. Participants will take either paricalcitol or pirfenidone by mouth every day for 12 weeks while continuing their standard chemotherapy, visit the clinic regularly for checkups and lab tests, keep a daily diary to track their study medication, and undergo a surgical re-evaluation after treatment to see if their tumor can be removed.

Official title: A Randomized Phase II Bayesian Pick-the-Winner Clinical Trial Investigating the Efficacy of Fibrosis-Modulating Agents (Paricalcitol and Pirfenidone) in Improving Surgical Resectability in Patients With Peritoneal Carcinomatosis Ineligible for Definitive Cytoreduction (Randy 1A)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2026-09

Completion Date

2030-11

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DRUG

Paricalcitol

Oral, 2 mcg once daily for 12 weeks

DRUG

pirfenidone

Oral, titrated up to 801 mg three times daily (total daily dose: 2403 mg/day) with food for 12 weeks.