TheraSphere™ Y-90 Glass Microspheres

ROWAN study

ROWAN study overview

ROWAN will explore if there is a benefit of TheraSphere Y-90 Glass Microspheres with immunotherapy to improve response for HCC patients.

Learn more about the clinical trial

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Study design

HCC

100 patients

Global study

Up to 50 sites

Summary

The ROWAN study is a global, open-label, multi-center, phase II, single-arm study to assess the efficacy of TheraSphere Y-90 Glass Microspheres followed by Durvalumab (Imfinzi®) with Tremelimumab (Imjudo®) (STRIDE regimen) in patients with hepatocellular carcinoma.

Caution: New Drug - Limited by Federal (or United States) law to investigational use.

Patient Criteria

Patients ≥ 18 years old of age with HCC who are not eligible for, or who have declined treatment with resection, ablation or liver transplant, will be considered for participation in this trial.

Treatment

Patients will receive TheraSphere Y-90 treatment followed by a single dose of Tremelimumab in combination with Durvalumab which is given every 4 weeks to maximum of 18 months.

Primary outcome measures

Assessment of the efficacy of TheraSphere followed by Durvalumab with Tremelimumab in HCC patients.

Objective response rate (ORR)

Complete response and partial response evaluated by mRECIST.

Secondary outcome measures

To explore whether systemic treatment with Durvalumab and Tremelimumab after TheraSphere can enhance other efficacy endpoints.
To assess the safety and toxicity of TheraSphere followed by Durvalumab and Tremelimumab.
To determine tumor and normal tissue absorbed radiation dose and its relationship with response, outcomes, and liver volume changes after treatment.
To determine if there is a difference in quality of life before and after treatment using the FACT-Hep and EQ-5D questionnaires.

Learn more about the full study design, patient criteria, and endpoints

Referring physician information

If you have questions about the ROWAN study and patient eligibility, please contact one of the principal investigators below.

Sites

Mayo Clinic

City: Jacksonville, FL

Principal Investigator: Beau Toskich, MD  

Contact: Qandeel Anwar

Georgetown University

City: Washington, DC

Principal Investigator: Aiwu Ruth He, MD, PhD

Contact: David Odhiambo Seeh, MS, B.Sc, HND

Medstar Georgetown University Hospital, Lombardi Comprehensive Cancer Center

City: Washington, DC

Principal Investigator: Aiwu Ruth He, MD, PhD

Contact: Shelley Collins

University of Minnesota

City: Minneapolis, MN

Principal Investigator: Siobhan Flanagan, MD

Contact: Connie Dale

Washington University (Barnes-Jewish Hospital)

City: St. Louis, MO

Principal Investigator: J. Daniel Giardina, MD

Contact: Tami Perkins, RN

Indiana University Medical Center

City: Indianapolis, IN

Principal Investigator: Paul Haste, MD

Contact: Eric Grubbs

Rush University Medical Center

City: Chicago, IL

Principal Investigator: Audrey Kam, MD

Contact: Jesse Molina

University of Chicago Hospital

City: Chicago, IL

Principal Investigator: Anjana Pillai, MD

Contact: Aurelie Desgardin

NYU Langone Health

City: New York, NY

Principal Investigator: Nina Beri, MD

Contact: Dunbar Sharpe

Ochsner Clinic Foundation

City: New Orleans, LA

Principal Investigator: Lingling Du, MD

Contact: Jessica Denaud, Nicole Perry

Clinicia Universitaria de Navarra

City: Pamplona, Navarre, Spain

Principal Investigator: Bruno Sangro, MD

Contact: Andoni Salvatierra

Hosp. Universitario Central de Asturias

City: Oviedo, Asturias, Spain

Principal Investigator: Maria Varela, MD

Hospital Universitario Ramon y Cajal

City: Madrid, Spain

Principal Investigator: José Luis Lledó, MD

Contact: Carolina Garcia, José Luis Lledó, MD, Antonio Guerrero, MD

CRLCC Eugene Marquis

City: Rennes, France

Principal Investigator: Julien Edeline, MD

Contact: Clarisse Rechede

CHU LILLE – Hôpital Huriez

City: Lille, France

Principal Investigator: Massih Ningarhari, MD

Hôpital HENRI MONDOR

City: Créteil, France

Principal Investigator: Hélène Regnault, MD

AP-HP, Hospital Beaujon

City: Clichy, France

Principal Investigator: Mohamed Bouattour, MD

Centre Hospitalier Universitaire de Nantes

City: Nantes, France

Principal Investigator: Yann Touchefeu, MD

Clinical trial managers

For more information about the ROWAN study, please contact the clinical trial manager.

Patrice Feaster at patrice.feaster@bsci.com

See more TheraSphere clinical data

TheraSphere indications, safety, and warnings

TheraSphere is a registered trademark of Theragenics Corporation used under license by Boston Scientific Medical Device Limited, a wholly owned indirect subsidiary of Boston Scientific Corporation.

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