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ACTIVE NOT RECRUITING
NCT05170438
PHASE2

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

Sponsor: National Health Research Institutes, Taiwan

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2022-07-01

Completion Date

2028-06

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DRUG

Lenvatinib Pill,Paclitaxel

Regimen Every 28 days as one cycle.Lenvatinib 16 or 12 mg/day orally (depends on the result of safety run-in phase), on day 1-28; Paclitaxel 80 mg/m2 in 250-500 mL of normal saline, intravenously over 2 hours on day 1, 8, 15.

Locations (8)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital

Taoyuan District, Taiwan