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RECRUITING
NCT05640791
PHASE2

Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with 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. Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy and Durvalumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Official title: Phase II, Single-arm, Exploratory Study to Evaluate the Safety and Effectiveness of Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-01-12

Completion Date

2026-12-31

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

DRUG

Cisplatin

25mg/m2;d1, 8, 21 d cycle

DRUG

Gemcitabine

1000mg/m2;d1, 8, 21 d cycle

DRUG

Nab-paclitaxel

100mg/m2;d1, 8, 21 d cycle

DRUG

Durvalumab

1000mg;d1, 21 d cycle

Locations (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China