Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recur… (NCT03847428) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
United States, Australia, Austria908 participantsStarted 2019-04-29
Plain-language summary
A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
Who can participate
Age range
18 Years – 150 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
* Imaging to confirm disease-free status within 28 days prior to randomization
* ECOG 0-1 at enrolment
* Child-Pugh score of 5 or 6
* Adequate organ and marrow function.
Exclusion Criteria:
* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
* Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
* History of hepatic encephalopathy within 12 months prior to randomization
* Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
* Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
* Active co-infection with HBV and HDV.
* Receipt of prior systemic anticancer therapy for HCC
* Those on a waiting list for liver transplantation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence-free survival (RFS) for Arm A vs Arm C
Timeframe: Up to 49 months after first patient randomized