A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and … (NCT06040099) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE
United States58 participantsStarted 2024-02-13
Plain-language summary
The purpose of this study is to measure the efficacy and safety of durvalumab intravenous (IV) solution plus bevacizumab IV solution after transarterial radioembolization (Yttrium 90 glass microspheres TARE) in participants with unresectable hepatocellular carcinoma (HCC) amenable to embolization.
Who can participate
Age range
18 Years – 130 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:
* Participants with confirmed unresectable HCC
* Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume.
* Participants with more than 1 prior embolization are permitted if more than 12 months ago, for a different primary lesion, and FLR \> 30%.
* Participants with no evidence of extrahepatic disease on any available imaging
* Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE.
* Participants having Child-Pugh score class A.
* Participants having ECOG performance status of 0 or 1 at enrollment
* Adequate organ and marrow function
Exclusion Criteria:
* Disease amenable to curative surgery, ablation or transplantation. Transplant patients are considered eligible if outside of Milan criteria and not currently listed for transplant.
* Participants co-infected with HBV and HDV
* Any history of nephrotic or nephritic syndrome.
* Clinically significant (eg, active) cardiovascular disease
* Participants with uncontrolled hypertension
* History of hepatic encephalopathy
* Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis.
* Receipt of more than 1 prior embolization (TACE or TARE) treatment/pr…
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
Progression Free Survival (PFS)
Timeframe: From Day 1 until date of progressive disease or death [Approximately 3 years]