Study on Durvalumab Alone or with Bevacizumab for Preventing Return of Liver Cancer After Treatment
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03847428
This global clinical trial is testing whether the drug durvalumab, alone or combined with bevacizumab, can help prevent the return of liver cancer in patients who have a high risk of recurrence after successful treatment.
Patient Parameters
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Program Overview
The study aims to find out if using durvalumab, either by itself or with bevacizumab, is effective and safe in preventing the return of liver cancer in patients who have recently undergone successful surgery or ablation to remove the cancer. This trial is for patients with hepatocellular carcinoma (HCC) who are at high risk of the cancer coming back.
Description
This is a large, international study where participants are randomly assigned to receive either durvalumab with bevacizumab, durvalumab alone, or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment. The goal is to see if these treatments can help prevent liver cancer from returning in patients who have already had successful surgery or ablation to remove the cancer. The study will monitor the safety and effectiveness of these treatments in patients who are at high risk of their cancer coming back.
Eligibility Criteria
Inclusion Criteria
- Recently diagnosed with liver cancer (HCC) and have completed successful treatment to remove it through surgery or ablation.
- Must have imaging tests showing no signs of cancer within 28 days before starting the study.
- Must be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have a Child-Pugh score of 5 or 6, indicating good liver function.
- Must have adequate organ and bone marrow function as determined by specific medical tests.
Exclusion Criteria
- Have a specific type of liver cancer known as fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma and HCC.
- Have evidence of cancer spread, large blood vessel invasion, or another type of cancer on initial imaging tests.
- Have had liver-related brain issues (hepatic encephalopathy) in the past year.
- Have varices (enlarged veins) at risk of bleeding as seen on medical imaging or endoscopy.
- Have certain types of blood vessel blockages in the liver (Vp1 to Vp4 portal vein thrombosis).
- Have active co-infection with hepatitis B and D viruses.
- Have received previous systemic cancer treatment for HCC.
- Are on a waiting list for a liver transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 35233 | Birmingham | Alabama |
| Research Site | 36604 | Mobile | Alabama |
| Research Site | 85054 | Phoenix | Arizona |
| Research Site | 92627 | Costa Mesa | California |
| Research Site | 92093-0698 | La Jolla | California |
| Research Site | 90806 | Long Beach | California |
| Research Site | 92868 | Orange | California |
| Research Site | 95817 | Sacramento | California |
| Research Site | 20007 | Washington D.C. | District of Columbia |
| Research Site | 33176 | Miami | Florida |
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