A Phase 2 interventional study of Durvalumab and Bevacizumab in Hepatocellular Carcinoma (HCC), sponsored by AstraZeneca. Active, not recruiting at 21 sites in United States. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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.
A Phase II single-arm study conducted in participants with unresectable Hepatocellular carcinoma (HCC) eligible for embolization and not eligible for or who have declined treatment with resection and/or ablation or liver transplant.
Participants with previous Transarterial Chemoembolization (TACE) or TARE associated with the curative setting are permitted with a 6-month washout.
Approximately 120 participants with unresectable but amenable to locoregional therapy HCC eligible for embolization will be screened in the study at approximately 20 sites in the US to enroll approximately 60 participants.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's enrollment of 58 is close to the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo Yttrium 90 glass microspheres TARE according to the dosimetry recommendation.
Drug: Durvalumab · Drug: Bevacizumab · Procedure: Transarterial Radioembolization (TARE)
Durvalumab IV (intravenous)
Also known as: MEDI4736, IMFINZI
Bevacizumab IV (intravenous)
Also known as: AVASTIN, ZIRABEV
Yttrium 90 glass microspheres will be administered
Also known as: TheraSphere
Progression Free Survival (PFS)
PFS is defined as the time from Day 1 (day of TARE) until the date of progressive disease per modified Response Evaluation Criteria in Solid Tumors (mRECIST), as assessed by the investigator, or death due to any cause. It is measured to assess the efficacy of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
Time frame: From Day 1 until date of progressive disease or death [Approximately 3 years]
Number of participants with Adverse events (AEs)
To assess the safety of the sequence of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy
Time frame: From Screening (Day -28 to Day 1) until 90 days after the last dose of study drug
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a confirmed complete response or partial response, as determined by the investigator per mRECIST. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
Time frame: From Day 1 until progression, or the last evaluable assessment in the absence of progression (Approximately 3 years)
Overall Survival (OS)
OS is defined as the time from the start of TARE until the date of death due to any cause. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
Time frame: Day 1 to 18 months or until death (Approximately 3 years)
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response (that is subsequently confirmed) until the date of documented progression per mRECIST as assessed by the investigator, or death due to any cause. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
Time frame: Time from first documented response until documented progression (Approximately 3 years)
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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