Phase II study of atezolizumab plus bevacizumab combination therapy for the patients with unresectable hepatocellular carcinoma and Child-Pugh B

JRCT ID: jRCTs031210355

Registered date:01/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 16/12/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Atezolizumab plus bevacizumab combination therapy

Outcome(s)

• Primary Outcome: Severe adverse events
• Secondary Outcome: Liver-related adverse events, immune-related adverse events, adverse events, trends of Child-Pugh scores and ALBI scores, objective response rate, progression-free survival, time to progression, overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Clinically diagnosed as hepatocellular carcinoma
2) Unsuitable for local therapy
3) Child-Pugh score of 7 or 8
4) 20 years old or older
5) ECOG Performance status of 0 or 1
6) Presence of target lesion
7) No prior systemic therapy
8) Preserved major organ function
9) Written informed consent

Exclude criteria

1) Active double cancer
2) Active infection requiring systemic treatments
3) Fever of 38 degrees celsius or higher
4) Pregnant or lactating women, or women of childbearing potential or her partner
5) Mental disorder
6) Autoimmune disease
7) Taking antiplatelet or anticoagulant medication
8) A history of hepatic encephalopathy within 3 months
9) Refractory ascites
10) Bleeding risk of esophageal and gastric varices
11) Metastases to central nervous system
12) Severe complication
13) Patients who investigator regards as inappropriate for candidate

Related Information

• Primary Sponsor: Ikeda Masafumi
• Secondary Sponsor: JON-HBP