Study on Durvalumab or Placebo with Gemcitabine and Cisplatin for First-Line Treatment of Advanced Biliary Tract Cancer (TOPAZ-1)
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03875235
This clinical trial is testing whether adding the drug Durvalumab to the standard chemotherapy treatment of Gemcitabine and Cisplatin can improve outcomes for patients with advanced biliary tract cancer. Some patients will receive a placebo instead of Durvalumab to compare the effects.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine if the addition of Durvalumab, an immunotherapy drug, to the standard chemotherapy regimen of Gemcitabine and Cisplatin can provide better results for patients who are receiving their first treatment for advanced biliary tract cancer. The study will compare the effects of Durvalumab with a placebo to see if it offers any additional benefits.
Description
This is a Phase III clinical trial, which means it is in the later stages of testing and involves a larger group of participants. The study is randomized, meaning patients are randomly assigned to receive either the experimental treatment or a placebo. It is also double-blind, so neither the patients nor the researchers know who is receiving the actual drug or the placebo, ensuring unbiased results. The trial is being conducted across multiple regions internationally, involving patients with advanced biliary tract cancers who are receiving their first line of treatment. The main goal is to see if Durvalumab, when combined with the chemotherapy drugs Gemcitabine and Cisplatin, can improve patient outcomes compared to the standard treatment alone.
Eligibility Criteria
Inclusion
- Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
- Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
- Patient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
- WHO/ECOG PS of 0 or 1
Exclusion
- History of another primary malignancy
- Brain metastases or spinal cord compression
- Uncontrolled intercurrent illness
- Major surgical procedure within 28 days prior to the first dose of IP.
- Prior locoregional therapy such as radioembolization
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 90027 | Los Angeles | California |
| Research Site | 92868 | Orange | California |
| Research Site | 20007 | Washington D.C. | District of Columbia |
| Research Site | 33905 | Fort Myers | Florida |
| Research Site | 33705 | St. Petersburg | Florida |
| Research Site | 66205 | Westwood | Kansas |
| Research Site | 40202 | Louisville | Kentucky |
| Research Site | 01805 | Burlington | Massachusetts |
| Research Site | 63110 | St Louis | Missouri |
| Research Site | 27514 | Chapel Hill | North Carolina |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.