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Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract Cancer

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Interventions: Oxaliplatin (Drug), Trifluridine/tipiracil (Drug) to Oxaliplatin (Drug), Trifluridine/tipiracil (Drug)
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 1 of 12 entries
    • Publications: details revised at 2 of 2 entries
  2. Start date changed from estimate of Dec 2025 to Dec 1, 2025v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2025 to Dec 2025
    • Site details revised at 2 of 2 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine/tipiracil (FTD/TPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD/TPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).
Trial Details
NCT Number NCT07146646
Lead Sponsor Case Comprehensive Cancer Center
Collaborators: National Comprehensive Cancer Network
Conditions
(from sponsor)		 Biliary Tract Cancer, Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Cancer, Gallbladder Carcinoma
Related terms Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov