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
Primary:
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:
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 further assess ORR after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy
To further assess OS after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy
To further assess DoR after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy
Exploratory:
To further assess the pattern of progressive disease after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy
To describe tumor and normal tissue absorbed radioembolization dose and its
relationship with response and outcomes and liver volume changes after treatment.
To assess participant-reported diseaseand treatment-related symptoms and HRQoL in participants with unresectable HCC amenable to locoregional therapy
MEDI4736 (Durvalumab)
- Rutgers University
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 or transplantation or curative ablation. - 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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