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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210355
Enrollment
30
Registered
2021-10-01
Start date
2021-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma Systemic therapy

Interventions

Atezolizumab plus bevacizumab combination therapy

Sponsors

Ikeda Masafumi
Lead Sponsor
JON-HBP
Collaborator

Eligibility

Sex/Gender
All

Inclusion 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

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 11) Metastases to central nervous system 12) Severe complication 13) Patients who investigator regards as inappropriate for candidate

Design outcomes

Primary

MeasureTime frame
Severe adverse events

Secondary

MeasureTime frame
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

Contacts

Public ContactMasafumi Ikeda

National Cancer Center Hospital East

masikeda@east.ncc.go.jp+81-4-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026