Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

28 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

74

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Paricalcitol Arm

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

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

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

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Paricalcitol Efficacy
Tijdsspanne: 12 weeks from treatment initiation

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

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Severity of Treatment-Emergent Adverse Events for Paricalcitol [Safety]
Tijdsspanne: 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]
Tijdsspanne: 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
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Patrick Wagner, MD, FACS

Onderzoekers

  • Hoofdonderzoeker: Patrick Wagner, AHN Health Network

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2030

Studie voltooiing (Geschat)

1 november 2030

Studieregistratiedata

Eerst ingediend

16 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 september 2026

Eerst geplaatst (Werkelijk)

5 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

28 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-077

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren