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Gemcitabine

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one arm Lenvatinib 16 or 12 mg/day orally day 1-28; Paclitaxel 80 mg/m2 in 250-500 mL of normal saline, intravenously over 2 hours on day 1, 8, 15;

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.

Lenvatinib Pill,Paclitaxel

Tsang-Wu Liu, MD

Nai-Jung Chiang, MD PHD

Li-yuan Bai, MD PHD

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

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

1.Safety run-in phase: 3-6 cases Traditional 3+3 design is applied for the determination of initial lenvatinib dose.2 Extension phase:3.

The estimated number of patients in current trial is calculated with Simon's minimax two-stage analysis

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment	NCT05170438	Advanced Biliar...	Lenvatinib Pill...	20 Years -	National Health Research Institutes, Taiwan
Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment	NCT05170438	Advanced Biliar...	Lenvatinib Pill...	20 Years -	National Health Research Institutes, Taiwan
Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment	NCT05170438	Advanced Biliar...	Lenvatinib Pill...	20 Years -	National Health Research Institutes, Taiwan

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