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

Advanced Biliary Tract Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

1. Safety run-in phase: 3-6 cases Traditional 3+3 design is applied for the determination of initial lenvatinib dose.

2. Extension phase:

The estimated number of patients in current trial is calculated with Simon's minimax two-stage analysis. Considering the response rate is at least 10% higher (based on Ueno's data) than the 5% response rate of mFOLFOX in patients who fail gemcitabine plus cisplatin in ABC-06 trial, the assumption of response rate of lenvatinib plus paclitaxel will is 15% or higher. Therefore, Simon's minimax two-stage design is applied with P0 = 5%, P1 = 15%, error 0.10, and errors 0.20. If tumor response is not observed in the first 29 patients, the study will be stopped. Otherwise, 15 additional patients be accrued for a total of 44. The null hypothesis will be rejected if 5 or more subjects have tumor response to the treatment of lenvatinib plus paclitaxel in 44 patients. If the investigators assume that drop-out rate is 10%, total accrual patient will be 49.

3. Total case number = patients in safety run-in phase + patients in extension phase = (3 - 6) + 49 = 52 - 55 ;

Related Conditions & MeSH terms

• Advanced Biliary Tract Cancer
• Biliary Tract Neoplasms

• NCT number: NCT05170438
• Study type: Interventional
• Source: National Health Research Institutes, Taiwan
• Contact: Tsang-Wu Liu, MD
• Phone: +886-2-26534401
• Email: walter@nhri.org.tw
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2022
• Completion date: June 30, 2028