NCT06708858

Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Dai, Guanghai · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well gemcitabine, cisplatin and durvalumab/Pembrolizumab and surufatinib work in treating participants with advanced 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. Whether if adding surufatinib to a standard of care can bring addition benefit needs to be explored.

Conditions

• Advanced Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Surufatinib	200mg，qd，po
DRUG	Gemcitabine	1000mg/ m2, IV，d1，8，q3w
DRUG	Cisplatin	25mg/m2，IV，d1，8，q3w
DRUG	Durvalumab	1500mg，IV，d1，q3w
DRUG	Pembrolizumab	200mg，IV，d1，q3w

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-12-01
• Completion: 2027-07-01
• First posted: 2024-11-27
• Last updated: 2024-11-27

Locations

1 site across 1 country: China