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RECRUITING
NCT06708858
PHASE2

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

Sponsor: Dai, Guanghai

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2024-08-15

Completion Date

2027-07

Last Updated

2024-11-27

Healthy Volunteers

No

Interventions

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

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China