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Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment

Study acronym: LenPac
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Primary completion date: Jun 30, 2026 to Jun 2028
    • Study completion date: Jun 30, 2028 to Jun 2028
    v7
  3. Collaborators: 6 to 7v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 55 to confirmed 51
    • Study sites: 1 to 8
    • Study description revised
    v5
  5. Re-verified, no change to tracked fieldsv4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  2. Interventions: Lenvatinib Pill (Drug) to Lenvatinib Pill,Paclitaxel (Drug)
    • Study description revised
    • Eligibility criteria expanded, about 3 words
    • Study title shortened, about 4 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To evaluate the following items in patients with advanced cholangiocarcinoma receiving lenvatinib plus paclitaxel treatment, Primary endpoint: Overall response rate (ORR) by RECIST 1.1 Secondary endpoints Progression-free survival (PFS) Time to progression Overall survival Disease control rate (Overall response rate + stable disease ≧ 4 weeks) Response rate by modified RECIST Association between therapeutic efficacy and tumor vascularity Quality of life Safety profile Predictive biomarker of cholangiocarcinoma
Trial Details
NCT Number NCT05170438
Lead Sponsor National Health Research Institutes, Taiwan
Collaborators: National Cheng-Kung University Hospital, National Taiwan University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, China Medical University, Taiwan, Mackay Memorial Hospital
Conditions
(from sponsor)		 Advanced Biliary Tract Cancer
Related terms Biliary Tract Neoplasms
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov