Clinical Trial

A Study to See the Effects That a New Combination of the Three Drugs, Nab-paclitaxel, Gemcitabine, and Cisplatin Has on Biliary Tract Cancer

Study acronym: AX-CSARC
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
You are being asked to take part in this study because you have a biliary cancer that is incurable and has spread to other organs. Chemotherapy is often used to help shrink the cancer temporarily and may improve survival. In Canada, the combination of gemcitabine and cisplatin is the chemotherapy combination used to treat biliary cancer that has spread. There is no other known treatment for biliary cancer that has spread to other organs. It is hoped that this new combination of drugs (nab-paclitaxel, gemcitabine, and cisplatin) will improve the tumor shrinkage rate. This study is being done because we do not know whether 2 or 3 chemotherapy drugs is better to treat biliary cancers. We hope to learn whether giving nab-paclitaxel, gemcitabine, and cisplatin together in patients with biliary cancer can increase tumor shrinkage without too many side effects. The purpose of this study is to find out what effects (good and bad) nab-paclitaxel, gemcitabine, and cisplatin has on you and your biliary cancer.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2015-12-15; most recent amendment 2025-06-24.
Status change: Recruiting → Active, Not Recruiting 2024-01-29
Status change: Not Yet Recruiting → Recruiting 2016-08-18
Trial Details
NCT Number NCT02632305
Lead Sponsor AHS Cancer Control Alberta
Collaborators: Celgene
Conditions Unresectable Biliary Tract Cancer
Enrollment 45 participants
Start Date 2016-07-13
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-26