NCT05640791

Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

Phase II, Single-arm, Exploratory Study to Evaluate the Safety and Effectiveness of Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy and Durvalumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions

• Resectable Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	25mg/m2；d1, 8, 21 d cycle
DRUG	Gemcitabine	1000mg/m2；d1, 8, 21 d cycle
DRUG	Nab-paclitaxel	100mg/m2；d1, 8, 21 d cycle
DRUG	Durvalumab	1000mg；d1, 21 d cycle

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2022-12-07
• Last updated: 2022-12-07

Locations

1 site across 1 country: China