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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 15, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

December 31, 2025

Conditions
Biliary Tract Cancer
Interventions
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.

Trial Locations (4)

110001

Anshan Cancer Hospital, Anshan

The First Affiliated Hospital of Jinzhou Medical University, Jinzhou

First Hospital of China Medical University, Shenyang

Shenyang Fifth People's Hospital, Shenyang

All Listed Sponsors
lead

China Medical University, China

OTHER

NCT06255262 - Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer | Biotech Hunter | Biotech Hunter