A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE (EMERALD-Y90)

AstraZeneca

Status and phase: Active, not recruiting; Phase 2

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Procedure: Transarterial Radioembolization (TARE); Drug: Durvalumab; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06040099

D933GC00002

Details and patient eligibility

About

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.

Full 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/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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Yttrium 90 glass microspheres TARE in combination with Durvalumab and Bevacizumab

Experimental group

Description:

Participants will undergo Yttrium 90 glass microspheres TARE according to the dosimetry recommendation.

Treatment:

Drug: Bevacizumab

Drug: Durvalumab

Procedure: Transarterial Radioembolization (TARE)