NCT04656249

Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer

The Efficacy and Safety of Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, nonrandom, open-label study aiming to evluate the efficacy and safety of lenvatinib for patients with pretreated advanced biliary tract cancer.

Detailed description

Lenvatinib targets VEGFR1, 2, and 3, PDGFRα, Fibroblast growth factor receptor (FGFR), and the KIT and RET tyrosine kinases and was initially developed for use in various tumor types. This is a single-center, non-random, open-label study in participants with unresectable BTC and disease progression or failure following at least one chemotherapy regimen. This study contains three procedures: a pre-treatment procedure that will last within 21 days; a treatment procedure that will consist of study treatment cycles and tumor assessment conducted every 6-8 weeks; and a follow-up procedure that will begin immediately after the off-treatment visit and will continue as long as the participant is alive, unless the participant withdraws consent, or until the terminal of the study.

Conditions

• Cholangiocarcinoma
• Biliary Tract Cancer
• Targeted Therapy

Interventions

Type	Name	Description
DRUG	Lenvatinib	Drug doses for BTC are identical, being orally administered at 8mg/d to patients weighing \<60 kg and 12mg/d to those ≥60 kg.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-12-01
• Completion: 2021-05-01
• First posted: 2020-12-07
• Last updated: 2021-06-04

Locations

1 site across 1 country: China