Atezolizumab and Bevacizumab with Proton Radiotherapy for Unresectable Hepatocellular Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

November 16, 2023

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2030

Conditions
Hepatocellular Carcinoma Non-resectable
Interventions
DRUG

Atezolizumab

Atezolizumab 1200 mg will be administered as an IV infusion on Day 1 of each cycle, with cycles occurring every 3 weeks. The initial dose will be delivered over 60 (± 15) minutes, and if well-tolerated, subsequent infusions may be given over 30 minutes. For patients who achieve a complete response (CR) within one year of treatment, atezolizumab should be continuously used for a year. For patients who experience a partial response (PR), atezolizumab should be continued until achieving CR or experiencing progressive disease (PD). Patients with stable disease should receive atezolizumab for 6 months. In the case of PD, atezolizumab should be discontinued at the time when PD is confirmed.

DRUG

Bevacizumab

Bevacizumab 15 mg/kg will be administered as an IV infusion on Day 1 of each 3-week cycle. The initial dose will be delivered over 90 minutes (±15 minutes), and if well-tolerated, subsequent infusions may be given over 60 minutes. For patients who achieve a complete response (CR) within one year of treatment, bevacizumab should be continuously used for a year. In the case of patients experiencing a partial response (PR), bevacizumab should be continued until achieving CR or experiencing progressive disease (PD). Patients with stable disease should receive bevacizumab for 6 months. In the event of PD, bevacizumab should be discontinued when PD is confirmed. Temporary withholding or dose reduction of bevacizumab is permitted if patients experience adverse events such as bleeding episodes, severe hypertension, or proteinuria at the discretion of the treating physician.

RADIATION

Proton radiotherapy

"* 72.6 CGE in 22 fractions for tumors ≤1 cm from the hepatic hilum, bowel, and heart.~* 66 CGE in 10 fractions for tumors \>1 cm from the hepatic hilum, bowel, and heart."

Trial Locations (1)

333

RECRUITING

Chang Gung Memorial Hospital at Linkou, Taoyuan

All Listed Sponsors
lead

Chang Gung Memorial Hospital

OTHER