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

Completed

• Conditions: Hepatocellular carcinoma

• Registration Number: jRCTs031210355

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-01
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

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
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: single assignment

Primary Outcome Measures

Name	Time	Method
-		Severe adverse events