NCT05170438

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Detailed description

1. Safety run-in phase: 2-6 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 = (2 - 6) + 49 = 51 - 55

Conditions

• Advanced Biliary Tract Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2021-12-28
• Last updated: 2026-01-20

Locations

8 sites across 1 country: Taiwan