NCT06255262

Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer

Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer Whose Disease Did Not Progress After Completion of First-line Durvalumab Combined With Gemcitabine+Cisplatin Treatment

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Real-World Study of Durvalumab combined with Surufatinib as maintenance therapy in patients with advanced biliary tract cancer whose disease did not progress after completion of first-line Durvalumab combined with Gemcitabine+cisplatin treatment.

Detailed description

This is a single-arm, multicentre real-world study of Durvalumab combined with Surufatinib as maintenance therapy in patients with advanced biliary tract cancer whose disease did not progress after completion of first-line Durvalumab combined with Gemcitabine+cisplatin treatment.The primary purpose of the study is exploring the efficacy and safety of durvalumab in combination with surufatinib for the maintenance therapy of patients with advanced biliary tract cancer.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Surufatinib	(1) Safety introduction phase (6 cases): 250mg, oral, QD,after one cycle of combined treatment, the occurrence of DLT was evaluated: 1) If ≤1person occurs, continue the dose expansion study at that dose level. 2)In the event of DLT\> 1, then the dose of surufatinib was adjusted to 200mg，oral，QD,until disease progression or intolerance of toxicity. (2) Dose expansion phase (24 cases): RP2D, oral, QD,until disease progression or intolerance of toxicity.
DRUG	Durvalumab	1500mg, Q4W.iv.every 28 days; until disease progression or intolerance of toxicity.

Timeline

• Start date: 2024-02-15
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2024-02-13
• Last updated: 2024-02-13

Locations

4 sites across 1 country: China