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

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

Ikeda Masafumi

National Cancer Center Hospital East

6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

masikeda@east.ncc.go.jp

Ikeda Masafumi

National Cancer Center Hospital East

6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

+81-4-7133-1111

masikeda@east.ncc.go.jp

Complete

Oct. 01, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Both

Hepatocellular carcinoma

Atezolizumab plus bevacizumab combination therapy

Systemic therapy

Atezolizumab plus bevacizumab combination therapy

013

Severe adverse events

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

+81-4-7133-1111

none