RecruitingPhase 2NCT05640791

Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

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


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

40 participants

Start Date

Jan 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cisplatin, a drug called Durvalumab, and others for people with resectable biliary tract cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin

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

DRUGGemcitabine

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

DRUGNab-paclitaxel

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

DRUGDurvalumab

1000mg;d1, 21 d cycle


Locations(1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

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NCT05640791