drugset / Trial / NCT05640791

Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

NCT05640791 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-01-12
Primary completion
2023-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 25 mg/m2 —
Subject Durvalumab Monoclonal antibody 1000 mg —
Subject Gemcitabine Small molecule 1000 mg/m2 —
Subject Nab-paclitaxel Small molecule 100 mg/m2 —

Indications