TheraSphere With Durvalumab and Tremelimumab for HCC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 3, 2023

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Hepatocellular Carcinoma
Interventions
DEVICE

TheraSphere Y-90 glass microsphere therapy

TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.

DRUG

Durvalumab (Imfinzi) immunotherapy

"1500 mg, every 4 weeks that continues for a maximum duration of 18 months or until confirmed progression (by site assessment), unacceptable toxicity, study withdrawal, or study early termination by the sponsor. Treatment beyond confirmed radiographic progression is permitted per patient consent if the following criteria are met:~* Absence of clinical symptoms or signs indicating clinically significant disease progression~* No decline in performance status~* Absence of rapid disease progression or threat to vital organs or critical anatomical sites (i.e. new CNS metastasis, respiratory failure due to tumor compression, spinal cord compression) requiring urgent alternative medical intervention~* No other treatment discontinuation criteria are met"

DRUG

Tremelimumab immunotherapy

300 mg, single administration

Trial Locations (36)

1211

University Hospital Geneva (HUG), Geneva

3010

University Hospital of Bern, Bern

10032

Columbia University Irving Medical Center, New York

20007

Georgetown University, Washington D.C.

20010

MedStar Washington Hospital Center, Washington D.C.

20133

National Cancer Institute of Milan, Italy, Milan

31008

Clinica Universidad de Navarra, Pamplona

32224

Mayo Clinic, Jacksonville

33006

Hospital Universitario Central de Asturias, Oviedo

34295

CHU Montpellier, Montpellier

35042

CHU Nantes, Rennes

38043

CHU Grenoble, Grenoble

46026

Hospital Universitari, Valencia

47012

Clinico de Valladolid, Valladolid

49033

CHU Angers - Hôpital Hôtel Dieu, Nantes

55455

University of Minnesota, Minneapolis

59037

Chru De Lille, Lille

60612

Rush University Medical Center, Chicago

60637

University of Chicago Hospital, Chicago

63101

Washington University (Barnes-Jewish Hospital), St Louis

70121

Ochsner Clinic Foundation, New Orleans

84157

Intermountain Health, Salt Lake City

85724

University of Arizona- Banner Health, Tucson

92093

University of California San Diego, San Diego

92110

Hôpital Beaujon, Clichy

94010

Chu Henri Mondor, Créteil

94143

University of California San Francisco, San Francisco

94800

Hopital Paul Brousse, Villejuif

Unknown

CHU de Bordeaux - Hôpital Haut-Lévêque, Clermont-Ferrand

CRLCC Eugene Marquis, Rennes

IRCCS - Regina Elena Cancer Institute, Roma

Azienda Sanitaria Universitaria Integrata Friuli Centrale (ASU FC), Udine

Hospital Gregorio Maranon, Madrid

Hospital Universitario Virgen de las Nieves, Madrid

Hospital. Ramon Y Cajal, Madrid

08036

Hospital Clinic de Barcelona, Barcelona

Sponsors
All Listed Sponsors
collaborator

Biocompatibles UK Ltd

INDUSTRY

lead

Boston Scientific Corporation

INDUSTRY