JPRN-jRCTs031210355
Active, not recruiting
Phase 2
Phase II study of atezolizumab plus bevacizumab combination therapy for the patients with unresectable hepatocellular carcinoma and Child-Pugh B - CHALLENGE trial
Ikeda Masafumi0 sites30 target enrollmentOctober 1, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hepatocellular carcinoma
- Sponsor
- Ikeda Masafumi
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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