Clinical Trial

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

Study acronym: LenPac
Active, Not Recruiting Phase 2
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Summary
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
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-12-10; most recent amendment 2026-07-01.
Status change: Recruiting → Active, Not Recruiting 2025-05-05
Status change: Not Yet Recruiting → Recruiting 2022-07-27
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 Advanced Biliary Tract Cancer
Enrollment 51 participants
Start Date 2022-07-01
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-02