NCT05935579

Durvalumab and Lenvatinib With or Without Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

A Phase II, Multicenter, Randomized Study of Durvalumab and Lenvatinib With or Without Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Explore the impact of the first-line application of Durvalumab combined with Lenvatinib, with or without chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers.

Detailed description

This trial is a two-arm, randomized, multi-center phase II clinical study. Eligible subjects who meet the study criteria will be screened and randomized in a 1:1 ratio to receive treatment with intravenous infusion of Durvalumab combined with oral lenvatinib, with or without chemotherapy. The investigators will closely follow up and assess the efficacy and safety of the combined treatment, evaluate the progression-free survival of the subjects until progression occurs, and observe their overall survival as a secondary outcome.

Conditions

• Biliary Tract Neoplasms
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab 1500 mg will be administered intravenously once every three weeks, with intravenous infusion on Day 1 of each cycle.
DRUG	Lenvatinib Oral Product	The dose of lenvatinib is 12mg/day for patients with a body weight of ≥60 kg, and 8mg/day for patients with a body weight of \<60 kg, taken once daily.
DRUG	Chemotherapy	GEMOX regimen: Gemcitabine 1000mg/m2 will be administered intravenously over 30 minutes on Day 1 and Day 8; Oxaliplatin 100mg/m2 will be administered intravenously over 2 hours on Day 1, and the cycle will be repeated every 3 weeks.

Timeline

• Start date: 2022-12-14
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2023-07-07
• Last updated: 2023-11-15

Locations

1 site across 1 country: China