Overview

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

Status:
Not yet recruiting

Trial end date:
2028-06-30

Target enrollment:

Participant gender:

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

Phase:

Phase 2

Details

Lead Sponsor:

National Health Research Institutes, Taiwan

Collaborators:

Chang Gung Memorial Hospital
China Medical University, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
National Cheng-Kung University Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan

Treatments:

Lenvatinib
Paclitaxel