Global Study on TACE with Durvalumab and Bevacizumab for Liver Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03778957
This international clinical trial is testing a combination of treatments, including TACE, durvalumab, and bevacizumab, to see if they can improve outcomes for patients with liver cancer that cannot be cured with surgery or other standard treatments.
Patient Parameters
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Program Overview
This study is exploring whether combining transarterial chemoembolization (TACE) with the drugs durvalumab and bevacizumab can be more effective than TACE alone in treating liver cancer that hasn't spread outside the liver and can't be cured with surgery or other treatments. The trial will compare the safety and effectiveness of these treatments in patients from around the world.
Description
This Phase III study involves patients with liver cancer that is localized to the liver and cannot be treated with surgery or other curative methods. The study will test the effectiveness and safety of TACE, a procedure that delivers chemotherapy directly to the liver, when used alone or in combination with the drugs durvalumab and bevacizumab. Participants will be randomly assigned to receive either TACE alone or TACE with one or both of these drugs. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. The goal is to determine if the combination therapies can improve patient outcomes compared to TACE alone.
Eligibility Criteria
Inclusion Criteria
- Cancer that has not spread outside the liver.
- Cancer that cannot be cured with surgery, transplant, or other treatments but can be treated with TACE.
- A Child-Pugh score of class A to B7, indicating liver function, and an ECOG performance status of 0 or 1, indicating good overall health.
- Cancer that can be measured using specific medical criteria.
- Adequate organ and bone marrow function.
Exclusion Criteria
- History of kidney problems like nephrotic or nephritic syndrome.
- Significant heart disease or recent events like a heart attack or stroke within the last 6 months.
- Blood clotting disorders or recent major surgery (except biopsies) within the last 28 days.
- History of abdominal issues like fistulas, non-healing ulcers, or active bleeding in the last 6 months.
- Certain types of blood vessel blockages in the liver.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 92627 | Costa Mesa | California |
| Research Site | 92093-0698 | La Jolla | California |
| Research Site | 92868 | Orange | California |
| Research Site | 20007 | Washington D.C. | District of Columbia |
| Research Site | 32224 | Jacksonville | Florida |
| Research Site | 33136 | Miami | Florida |
| Research Site | 96819 | Honolulu | Hawaii |
| Research Site | 60612 | Chicago | Illinois |
| Research Site | 71103 | Shreveport | Louisiana |
| Research Site | 48201 | Detroit | Michigan |
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