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NCT07780838

Alternating Chemo-immunotherapy and FGFR Inhibitor for FGFR-positive Biliary or Cholangiocarcinoma

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Study title shortened, about 13 wordsv3
  2. Recruitment opened
    • Site details revised
    v2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Overall survival (OS)
Timeframe: At 12 months

Secondary (15)

Overall response rate (ORR)
Disease control rate
Duration of response
Duration of therapy (DOT)
Progression free survival (PFS)
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Overall survival
Percentage of patients who discontinue therapy
Percentage of patients who go on to receive second line treatment
Patient quality of life
Incidence of adverse events (AE)
Incidence of serious adverse events
Dose interruptions
Dose reductions
Dose intensity
Incidence of AE leading to study drug delay or discontinuation

Arms and interventions

Treatment (chemoimmunotherapy, FGFRi cycles)Experimental

See Detailed Description

Procedures: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging

Drugs: Cisplatin, Gemcitabine, Pemigatinib

Biologicals: Durvalumab

Other: Survey Administration

Sites

1 site in 1 country

  • Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United States