Study on Rilvegostomig or Durvalumab with Chemotherapy for First-Time Treatment of Biliary Tract Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07221253
This clinical trial is comparing two treatment options, Rilvegostomig and Durvalumab, both combined with chemotherapy drugs gemcitabine and cisplatin, to see which is more effective and safe for patients with advanced biliary tract cancer (BTC).
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to evaluate how well two different treatment combinations work for patients with advanced biliary tract cancer (BTC). The treatments being tested are Rilvegostomig with chemotherapy drugs gemcitabine and cisplatin, and Durvalumab with the same chemotherapy drugs. Researchers want to find out which combination is more effective and safe as a first treatment option for patients whose cancer has spread or cannot be removed by surgery.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with adenocarcinoma of the biliary tract, including types like intra-hepatic or extra-hepatic cholangiocarcinoma and gallbladder carcinoma.
- Cancer that cannot be surgically removed or has spread, and has not been treated before in its advanced stage.
- Known PD-L1 status, determined by a central lab using a suitable tumor sample.
- Cancer that can be measured accurately using CT or MRI scans.
- In good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate bone marrow and organ function as determined by specific medical tests.
Exclusion Criteria
- Have ampullary carcinoma.
- Have received any previous systemic therapy for advanced biliary tract cancer.
- Have been treated with any other therapies targeting immune system receptors or mechanisms.
- Are currently receiving any other cancer treatments, such as chemotherapy, radiotherapy, or immunotherapy, not included in this study.
- Have active or previously documented autoimmune or inflammatory disorders that require ongoing treatment with steroids or other immunosuppressive medications.
- Have active lung disease or inflammation, serious chronic digestive conditions causing diarrhea, or active skin diseases requiring systemic treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 35233 | Birmingham | Alabama |
| Research Site | 85719 | Tucson | Arizona |
| Research Site | 91010 | Duarte | California |
| Research Site | 92868 | Orange | California |
| Research Site | 90404 | Santa Monica | California |
| Research Site | 94305-5847 | Stanford | California |
| Research Site | 80045 | Aurora | Colorado |
| Research Site | 20007 | Washington D.C. | District of Columbia |
| Research Site | 30060 | Marietta | Georgia |
| Research Site | 60637 | Chicago | Illinois |
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