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

NCT06708858 Phase 2 RECRUITING

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.

Details

Lead sponsor	Dai, Guanghai
Phase	Phase 2
Status	RECRUITING
Enrolment	35
Start date	2024-08-15
Completion	2027-07

Conditions

• Advanced Biliary Tract Cancer

Interventions

• Surufatinib
• Gemcitabine
• Cisplatin
• Durvalumab
• Pembrolizumab

Primary outcomes

• ORR — Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks and then every 8 weeks, through study completion, an average of 1 year
  Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.

Countries

China