A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE

Launched by ASTRAZENECA · Sep 11, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with unresectable hepatocellular carcinoma (HCC), which is a type of liver cancer that cannot be surgically removed. The researchers want to find out how effective and safe it is to combine two medications, durvalumab and bevacizumab, with a procedure called transarterial radioembolization (TARE), which delivers targeted radiation to the liver tumors. The trial is currently recruiting participants who are between 18 and 81 years old and have confirmed unresectable HCC with certain criteria, such as having a specific liver function score and no signs of cancer spread outside the liver.

Eligible participants can expect to receive these treatments and be monitored for their health and response to therapy. It's important to note that those who have had prior cancer treatments or certain medical conditions, like significant heart disease or uncontrolled high blood pressure, may not qualify for this study. This trial may offer a potential new option for patients struggling with this challenging condition, and being part of the study could help advance our understanding of how to treat liver cancer effectively.

Gender

ALL

Eligibility criteria

• 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 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.
• • 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