Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01411436

Enrollment

1637

Registered

2011-08-08

Start date

2009-05-31

Completion date

2015-02-28

Last updated

2015-03-04

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

Conditions

Carcinoma, Hepatocellular

Keywords

Nexavar, unresectable hepatocellular carcinoma

Brief summary

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Nexavar for unresectable hepatocellular carcinoma (HCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 2 or 3 months (dependent on sites) for Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be recruited and followed one year since starting Nexavar administration.

Interventions

DRUGSorafenib (Nexavar, BAY43-9006)

Patients who have received Nexavar for unresectable HCC

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients who received Nexavar for unresectable hepatocellular carcinoma

Exclusion criteria

* Patients who are contraindicated based on the product label

Design outcomes

Primary

Measure	Time frame
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar	After Nexavar administration, up to 1 year

Secondary

Measure	Time frame
Demography	Baseline
Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST)	After Nexavar administration, up to 1 year
Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best response	After Nexavar administration, up to 1 year
The status of therapy with Nexavar [duration of treatment, daily dose] in a various settings according to baseline data [such as demographic data, Child-Pugh status, ECOG-PS]	After Nexavar administration, up to 1 year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026