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Retrospective observational study to investigate the predictive factors about the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.

Not Applicable
Completed
Conditions
Hepatocellular carcinoma
Registration Number
JPRN-UMIN000010001
Lead Sponsor
Japanese Red Cross Liver Study Group
Brief Summary

This study included 259 males and 57 females with a median age of 70 years, of which 191 (60.4%) were classified as Barcelona Clinic Liver Cancer stage C, and 271 (85.8%) had Child-Pugh class A liver function. The median overall survival time was 307 days and progression-free survival time was 109 days. According to the modified Response Evaluation Criteria In Solid Tumours, four patients achieved a complete response, 51 achieved a partial response, 136 had stable disease and 125 had progressive disease. Multivariate analysis identified female gender (P = 0.003) and decreased serum AFP level after 1 month (P = 0.042) as independent predictors of a complete or partial response.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
400
Inclusion Criteria

Not provided

Exclusion Criteria

none

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The clinicopathological factors related to time to progression of unresectable advanced hepatocellular carcinoma.patients treated with sorafenib.
Secondary Outcome Measures
NameTimeMethod
The clinicopathological factors related to overall survival of unresectable advanced hepatocellular carcinoma patients treated with sorafenib. The clinicopathological factors to predict serious adverse effects caused by sorafenib.
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