NCT05410197

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

Envofolimab and Lenvatinib in Combination With Gemcitabine Plus Cisplatin for Patients With Advanced Biliary Tract Cancer as First-Line Treatment: A Single-arm, Open-label, Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The trial will recruit 43 patients. At the first step, 10 patients will be recruited. Only when at least 4 patients achieve objective response will the trial enter the second step and continue to recruit other patients. After being enrolled, all patients giving written informed consent will receive treatment until progression of disease, unacceptable toxicity or death. The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.

Conditions

• Advanced Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Envofolimab	400mg by subcutaneous injection every 3 weeks
DRUG	Lenvatinib	8 mg orally once a day
DRUG	Gemcitabine	1000mg/m2 by intravenous infusions on day 1 and 8 every 3 weeks for up to 24 weeks
DRUG	Cisplatin	25mg/m2 by intravenous infusions on day 1 and 8 every 3 weeks for up to 24 weeks

Timeline

• Start date: 2022-10-10
• Primary completion: 2024-08-01
• Completion: 2025-08-01
• First posted: 2022-06-08
• Last updated: 2022-10-12

Locations

1 site across 1 country: China