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Open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.

Biocompatible resin microspheres are an injectable permanent implant and preferentially placed into the distal microvascular supply of tumors to provide direct irradiation of tissue and destruction of the microvascular bed. Spheres contain yttrium-90 (Y-90) and are a size between 20 and 60 microns in diameter.

Resin microspheres containing yttrium-90 (Y-90)

Janet Bell

Edward Lee, MD

Aniket Joglekar

Melinda Lima

Lillian Chen

Bhavraj Khalsa, MD

Study Hotline

Nadine Abi-Jaoudeh, MD

Raul Herrera, MD

Ivette Cruz, RN

Ripal Gandhi, MD

Kaiti Meek

Scott Perrin, MD

Maria Rivas

Peter Park, MD

Peyton Ackerman

Carissa Walter

Zachary Collins, MD

Joanna Johnston, RN

Eric Wehrenberg-Klee, MD

Marc McCall

Ema Pinjic

Ammar Sarwar, MD

Muneeb Ahmed, MD

Andrea Bullock, MD, MPH

Maria-Andreea Catana, MD

Jeffrey Weinstein, MD

Ramona Jayasena

Radiology Research

Stephen Reis, MD

Hannah Mignosa-Martin

Markeela Lipscomb

David Mauro, MD

Austin Humbert

Stacie Moore

Brian Kouri, MD

Ali Kord, MD

Lauren Cartheuser

Natasha Barnhill

Barbara McCain

Sameer Gadani, MD

Aamir Razak

Abashai Woodard

Gregory Nadolski, MD

Michael Soulen, MD

Susan Shamimi-Noori, MD

Caitlyn Copp-Millward

Andrew Klobuka, MD

Wendy Smith

Barbara Marcotte

Aaron Maxwell, MD

DaeHee Kim, MD

Araceli Torres

Shandra Silas

Parvez Mantry, MD

Bridgett Hobbs, RN

Donna Hall, RN

Ahmed Kamel Abdel Aal, MD

Rodrick Zvavanjanja, MD

Richard Tapnio, MD

Mihir Patel, MD

Alexa Levey, MD

Maria Briones

Armeen Mahvash

Armeen Mahvash, MD

S Cheenu Kappadath, MD

Beth Chasen, MD

John Little

Emma Armstrong

Bill Majdalany, MD

Brook Root

Marilee Walker

Douglas A Murrey Jr., MS, MD

Armeen Mahvash, M.D.

S. Cheenu Kappadath, Ph.D.

The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C.

SIR-Spheres consist of biocompatible resin microspheres containing yttrium-90 (Y-90), with a size between 20 and 60 microns in diameter. Y-90 is a high-energy pure beta-emitting isotope with no primary gamma emission.

SIR-Spheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1 and B2, maximal single lesion size of 8 cm, no macrovascular invasion, well-compensated liver function and good performance status. It is also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of Floxuridine (FUDR).

The investigation is a pivotal, prospective, multicenter, open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.

Up to 100 subjects will be treated (up to 150 consented) at up to 30 clinical sites in the United States.

The population for this study includes patients diagnosed with HCC BCLC stage A, B1, B2, and C with maximal single lesion size of ≤ 8cm and who are not considered suitable for treatment by resection or eligible for ablation at time of study entry.

A pivotal, prospective, multicenter, open-label single arm study

Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients

A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety & Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients

ORR uses a localized version of modified Response Evaluation Criteria in Solid Tumors ("localized mRECIST") criteria and best response through 9 months, in patients treated with SIR-Spheres Y-90 resin microspheres.

The interval from first time of response (complete response (CR) or partial response (PR)) until disease progression (PD) as defined by localized mRECIST criteria.

The severity of the adverse event should be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Liver resection as noted on follow-up case report form.

Liver transplant as noted on follow-up case report form.

Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire

EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire

Bright Research Partners

Sirtex Medical

Spots Global Cancer Trial Database for bclc stage a hepatocellular carcinoma