NCT07856914Not yet recruitingPhase 2
Paricalcitol Versus Pirfenidone for Improving Surgical Resectability in Patients With Peritoneal Cancer
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)
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 16 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2030
- Lead sponsor
- Patrick Wagner, MD, FACS
- Diseases
- Colorectal cancer, Ovarian cancer
- NCT number
- NCT07856914
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 74
- From Sept 2026 to the primary completion date, Sept 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Patients deemed eligible for definitive cytoreductive surgery
- Current or recent (within 30 days) use of paricalcitol, pirfenidone, or Vitamin D supplementation above USDA-recommended daily dosage
- Known allergy or medical contraindication to study drugs
- Hypersensitivity to any of the study drugs or to any ingredient in the formulation
- Receipt of any investigational drug within 30 days prior to initiation
- Active pregnancy or lactation
- Active smoking
- Active brain metastases
- Elevated Vitamin D level (\>2x upper limit of normal)
- Significant comorbidities including abnormal calcium/phosphate, history of serious drug-induced liver injury, severe cardiac conditions, patients with or predisposed to cardiac arrhythmias, or uncontrolled hypertension
- Concomitant medications that, after review by the study pharmacist(s) and potential dose modification in accordance with prescribing guidelines, still pose an unmanageable drug-drug interaction or unacceptable safety risk with either study drug
Who the study is looking for
- Males or females, age 18 to \<81 years at the time of consent
- Biopsy-proven peritoneal carcinomatosis
- Documented receipt of at least three months of standard systemic chemotherapy prior to initiation, with persistent disease
- ECOG Performance Status of 0 or 1
- Adequate organ function within 14 days prior to anti-fibrotic initiation
- Negative serum pregnancy test for women of childbearing potential (WOCBP) within 7 days prior to initiation
- Able to understand and provide written informed consent
- Willingness and ability to comply with all study procedures
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.