Clinical trial · Interventional
A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE
Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere™) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Transarterial Radioembolization (TARE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Yttrium 90 glass microspheres TARE in combination with Durvalumab and Bevacizumab
- description
- Participants will undergo Yttrium 90 glass microspheres TARE according to the dosimetry recommendation.
- interventionNames
- Drug: Durvalumab
- Drug: Bevacizumab
- Procedure: Transarterial Radioembolization (TARE)
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- From Day 1 until date of progressive disease or death [Approximately 3 years]
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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/procedure * Participant has received any prior anticancer systemic therapy for unresectable HCC. * History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment. * History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
References
Publications (1)
- DERIVEDPabon CM, Kumar-Sharma P, Spieler BO, Tuerff D, Datta J, Hosein PJ. Identifying Subsets of Patients with Non-immunogenic Gastrointestinal Cancers for Checkpoint Immunotherapy. Surg Oncol Clin N Am. 2026 Apr;35(2):347-365. doi: 10.1016/j.soc.2025.10.008. Epub 2026 Jan 14. PMID 41903993