Status:
RECRUITING
A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE
Lead Sponsor:
AstraZeneca
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief 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 microsphere...
Detailed Description
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/...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 23 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06040099
Start Date
February 13 2024
End Date
October 23 2026
Last Update
December 19 2025
Active Locations (25)
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1
Research Site
Aurora, Colorado, United States, 80045
2
Research Site
Gainesville, Florida, United States, 32608
3
Research Site
Miami, Florida, United States, 33136
4
Research Site
Miami, Florida, United States, 33176