Phase II study of atezolizumab plus bevacizumab combination therapy for the patients with unresectable hepatocellular carcinoma and Child-Pugh B
- Conditions
- Hepatocellular carcinomaSystemic therapy
- Registration Number
- JPRN-jRCTs031210355
- Lead Sponsor
- Ikeda Masafumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severe adverse events
- Secondary Outcome Measures
Name Time Method iver-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