Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 26, 2022

Primary Completion Date

July 25, 2026

Study Completion Date

January 31, 2028

Conditions
Locally Advanced Hepatocellular Carcinoma
Interventions
COMBINATION_PRODUCT

SIRT-Y90 with Atezolizumab + Bevacizumab

Single or two-staged delivery of SIRT-Y90 (4 to 6 weeks), followed by 1200mg atezolizumab + 15mg/kg bevacizumab administered by IV at every 3 weeks for 18 months.

COMBINATION_PRODUCT

SIRT-Y90 with Placebo (IV)

Single or two-staged delivery of SIRT-Y90 (4 to 6 weeks), followed by placebo at every 3 weeks for 18 months.

Trial Locations (14)

119074

RECRUITING

National University Hospital, Singapore

168583

RECRUITING

National Cancer Centre Singapore, Singapore

Unknown

RECRUITING

Beijing Tsinghua Changgung Hospital, Beijing

NOT_YET_RECRUITING

People's Liberation Army General Hospital (1st and 6th Medical Centre), Beijing

RECRUITING

West China Hospital, Sichuan University, Chengdu

NOT_YET_RECRUITING

Shandong Cancer Hospital, Jinan

RECRUITING

Samsung Medical Center, Seoul

RECRUITING

Seoul National University Hospital, Seoul

RECRUITING

Severance Hospital Yonsei University Health System, Seoul

RECRUITING

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

RECRUITING

Taichung Veterans General Hospital, Taichung

RECRUITING

National Taiwan University Cancer Center, Taipei

RECRUITING

National Taiwan University Hospital, Taipei

RECRUITING

Taipei Veterans General Hospital, Taipei

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

collaborator

Sirtex Medical

INDUSTRY

collaborator

Singapore Clinical Research Institute

OTHER

lead

National Cancer Centre, Singapore

OTHER

NCT05377034 - Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients | Biotech Hunter | Biotech Hunter