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Paricalcitol Versus Pirfenidone for Improving Surgical Resectability in Patients With Peritoneal Cancer (RANDY 1A)

28 september 2026 uppdaterad av: Patrick Wagner, MD, FACS

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)

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a single-center, randomized Phase II clinical trial designed to investigate the efficacy of repurposing fibrosis-modulating agents to improve surgical resectability in patients with peritoneal carcinomatosis. Peritoneal carcinomatosis is characterized by a challenging tumor microenvironment (TME) featuring extensive fibrosis and a high density of cancer-associated fibroblasts (CAFs). These elements create a dense desmoplastic barrier that impedes drug penetration, limits therapeutic efficacy, and frequently renders patients ineligible for definitive surgical cytoreduction.

To overcome these barriers, the trial evaluates two distinct anti-fibrotic agents: paricalcitol, a synthetic Vitamin D receptor agonist that promotes CAF quiescence and stromal remodeling, and pirfenidone, an oral anti-fibrotic agent that inhibits fibrosis by downregulating the TGF-β signaling pathway and collagen synthesis. Eligible participants are randomized in a 1:1 ratio to receive a 12-week course of either oral paricalcitol (2 mcg daily, titratable) or oral pirfenidone (titrated to 801 mg three times daily with food), administered concurrently with their ongoing standard systemic chemotherapy.

Studietyp

Interventionell

Inskrivning (Beräknad)

74

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Paricalcitol Arm

Participants receive oral paricalcitol once daily for 12 weeks concurrently with standard systemic chemotherapy.
Läkemedel: Paricalcitol

Oral, 2 mcg once daily for 12 weeks
Experimentell: Pirfenidone Arm

Participants receive oral pirfenidone three times daily for 12 weeks (with initial dose titration) concurrently with standard systemic chemotherapy.
Läkemedel: pirfenidone

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Paricalcitol Efficacy
Tidsram: 12 weeks from treatment initiation

Proportion of patients achieving a clinicopathologic response (CPR)
12 weeks from treatment initiation
Pirfenidone Efficacy
Tidsram: 12 weeks from treatment initiation

Proportion of patients achieving a clinicopathologic response (CPR)
12 weeks from treatment initiation

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Severity of Treatment-Emergent Adverse Events for Paricalcitol [Safety]
Tidsram: 16 weeks from treatment initiation

Maximum severity grade of treatment-emergent adverse events per participant, assessed on a scale from Grade 1 (mild) to Grade 5 (death) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Higher grades indicate a more severe outcome.
16 weeks from treatment initiation
Severity of Treatment-Emergent Adverse Events for Pirfenidone [Safety]
Tidsram: 16 weeks from treatment initiation

Maximum severity grade of treatment-emergent adverse events per participant, assessed on a scale from Grade 1 (mild) to Grade 5 (death) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Higher grades indicate a more severe outcome
16 weeks from treatment initiation
Incidence of Treatment-Emergent Adverse Events for Paricalcitol [Safety
Tidsram: 16 weeks from treatment initiation

Number of participants experiencing one or more treatment-emergent adverse events, as graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
16 weeks from treatment initiation
Incidence of Treatment-Emergent Adverse Events for Pirfenidone [Safety]
Tidsram: 16 weeks from treatment initiation

Number of participants experiencing one or more treatment-emergent adverse events, as graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
16 weeks from treatment initiation
Patient-Reported Quality of Life Outcomes Using the Medical Outcomes Study 20-Item Short-Form Health Survey (SF-20) for Paricalcitol [Tolerability]
Tidsram: 12 weeks

Assessment of patient-reported quality of life outcomes using the SF-20 questionnaire. Each subscale ranges from a minimum score of 0 to a maximum score of 100, where higher scores indicate a better health-related quality of life outcome.
12 weeks
Patient-Reported Quality of Life Outcomes Using the Medical Outcomes Study 20-Item Short-Form Health Survey (SF-20) for Pirfenidone [Tolerability]
Tidsram: 12 weeks

Assessment of patient-reported quality of life outcomes using the SF-20 questionnaire. Each subscale ranges from a minimum score of 0 to a maximum score of 100, where higher scores indicate a better health-related quality of life outcome.
12 weeks
Treatment Adherence Evaluated via Study Drug Diaries for Paricalcitol [Feasibility]
Tidsram: 12 weeks

Percentage of total prescribed doses taken based on study drug diaries (number of doses taken divided by total expected doses over 12 weeks).
12 weeks
Treatment Adherence Evaluated via Study Drug Diaries for Pirfenidone [Feasibility]
Tidsram: 12 weeks

Percentage of total prescribed doses taken based on study drug diaries (number of doses taken divided by total expected doses over 12 weeks).
12 weeks
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Paricalcitol [Efficacy]
Tidsram: 12 weeks

Evaluation of molecular correlates of treatment response using research blood samples collected at baseline and post-treatment.
12 weeks
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Pirfenidone [Efficacy]
Tidsram: 12 weeks

Evaluation of molecular correlates of treatment response using research blood samples collected at baseline and post-treatment.
12 weeks
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Paricalcitol [Efficacy]
Tidsram: 12 weeks

Evaluation of circulating biomarkers of treatment response using research blood samples collected at baseline and post-treatment.
12 weeks
Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Pirfenidone [Efficacy]
Tidsram: 12 weeks

Evaluation of circulating biomarkers of treatment response using research blood samples collected at baseline and post-treatment.
12 weeks
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Pirfenidone [Efficacy]
Tidsram: 12 weeks

Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in Ki-67 positive tumor cells
12 weeks
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Paricalcitol [Efficacy]
Tidsram: 12 weeks

Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in Ki-67 positive tumor cells
12 weeks
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Paricalcitol [Efficacy]
Tidsram: 12 weeks from treatment initiation

Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in density of Fibroblast Activation Protein-positive (FAP+)
12 weeks from treatment initiation
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Pirfenidone [Efficacy]
Tidsram: 12 weeks from treatment initiation

Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in density of Fibroblast Activation Protein-positive (FAP+)
12 weeks from treatment initiation
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Paricalcitol [Efficacy]
Tidsram: 12 weeks from treatment initiation

Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples measuring changes in collagen density (quantified via Sirius Red or Masson's Trichrome staining).
12 weeks from treatment initiation
Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Pirfenidone [Efficacy]
Tidsram: 12 weeks from treatment initiation

Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples measuring changes in collagen density (quantified via Sirius Red or Masson's Trichrome staining).
12 weeks from treatment initiation

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Patrick Wagner, MD, FACS

Utredare

  • Huvudutredare: Patrick Wagner, AHN Health Network

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2030

Avslutad studie (Beräknad)

1 november 2030

Studieregistreringsdatum

Först inskickad

16 september 2026

Först inskickad som uppfyllde QC-kriterierna

28 september 2026

Första postat (Faktisk)

5 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026-077

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Sharing of data or bio-specimens is not currently planned and will require a separate IRB application and a Material Transfer Agreement (MTA) or Data Use Agreement (DUA), as applicable, in the event that such plans arise in the future

Läkemedels- och apparatinformation, studiedokument

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Studerar en amerikansk FDA-reglerad produktprodukt

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produkt tillverkad i och exporterad från U.S.A.

Nej

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