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)

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objective:

To assess the efficacy of TARE followed by durvalumab monotherapy followed by durvalumab +bevacizumab by assessment of PFS in participants with unresectable HCC amenable to locoregional therapy

Secondary Objectives:

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
To assess ORR after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy
To assess OS after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy
To assess DoR after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy

Eligibility

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.

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices