drugset / Trial / NCT05410197

Envofolimab and Lenvatinib Combined With Gemcitabine Plus Cisplatin for Advanced BTC as First-Line Treatment(ENLIGHTEN)

NCT05410197

Phase 2 Unknown 43 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

This is a phase 2, single-arm, open label study. The purpose is to investigate both the efficacy and safety of Envofolimab and Lenvatinib in combination with Gemcitabine plus Cisplatin for treatment of advanced biliary tract cancer as first-line treatment.

Timeline

Start
2022-10-10
Primary completion
2024-08-01
Completion
2025-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Envofolimab Unknown 400 mg Subcutaneous
Subject Lenvatinib Small molecule 8 mg Oral
Background Cisplatin Other / unclassified 25 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications