Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma

Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma - Safety and Efficacy Study of Sorafenib in Japanese patients with Advanced Hepatocellular Carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004215

Enrollment

100

Registered

2010-10-01

Start date

2010-05-01

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

Advanced Hepatcellular Carcinoma

Interventions

Sorafenib 400mg twice daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Age >= 20 years 2)Patients who have been diagnosed with hepatocellular carcinoma by histologycally or typical diagnostic images 3)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy, transcatheter arterial chemoembolization, radiation therapy) 4)Child-Pugh A or B 5)Performance status (ECOG scale): 0,1 or 2 6)Life expectancy of at least 12 weeks 7)At least 1 target lesion measurable 8)Adequate organ function

Exclusion criteria

Exclusion criteria: 1)Second primary malignancy 2)Severe cardiac complication 3)Active infection 4)HIV infection 5)Encephalopacy 6)Gastro-esophazeal varices requiring preventive treatment 7)Uncontrolled massive ascitis

Design outcomes

Primary

Measure	Time frame
Time to Progression (TTP)	—

Countries

Japan

Contacts

Public ContactSadahisa Ogasawara

Chiba University Hospital Department of Gastroenterology

ogasawaras@graduate.chiba-u.jp

Outcome results

None listed

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