ROWAN study overview
ROWAN will explore if there is a synergistic benefit of TheraSphere Y-90 Glass Microspheres with immunotherapy to improve response to cancer therapy in early and intermediate stage HCC patients.
ROWAN will explore if there is a synergistic benefit of TheraSphere Y-90 Glass Microspheres with immunotherapy to improve response to cancer therapy in early and intermediate stage HCC patients.
*CAUTION: In the U.S. TheraSphere is under an investigational device exemption for treatment of patients with metastatic colorectal cancer. The safety and effectiveness for this treatment has not been established.
To assess the durability of local tumor control in HCC patients who receive TheraSphere followed by Durvalumab and Tremelimumab, compared to those who receive TheraSphere treatment alone.
Objective Response Rate (ORR) [ Time Frame: Treatment (Day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is randomized) ] Complete response and partial response evaluated by localized modified Response evaluation Criteria in Solid Tumors (mRECIST).
Duration of response (DoR) [ Time Frame: Time of response up to progression, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is randomized) ] According to localized mRECIST.
TheraSphere is a registered trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd., a wholly owned subsidiary of Boston Scientific Corporation.