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Sorafenib Concomitantly Used With TACE (Transarterial Chemoembolization) in uHCC (Unresectable Hepatocellular Carcinoma) Patients in China

NCT ID: NCT01839630

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

302 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-30

Study Completion Date

2016-12-29

Brief Summary

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This study is to obtain the characteristics and treatment pattern of the unresectable HCC patients who are candidates for systemic therapy and in whom a decision to treat with sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd TACE procedure) has been made under real-life practice conditions.this study will also conclude the safety and effectiveness of combination in uHCC patients.

Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Keywords

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Sorafenib Hepatocellular cancer TACE combination Treatment pattern Safety Effectiveness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Sorafenib (Nexavar, BAY43-9006)

Intervention Type DRUG

sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator

Interventions

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Sorafenib (Nexavar, BAY43-9006)

sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically/ cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI;
* Patients receive the first dose of sorafenib no later than 1 week (\<=7days) after the 3rd TACE procedure
* Patients did not receive other prior systemic treatment by using target therapy
* Patients must sign the informed consent form;
* Patients must have a life expectancy of at least 3 months;
* The physician must be willing to complete and submit all CRFs;
* The physician must be willing to submit to a site audit with verification of source documents and validation of data reported;

Exclusion Criteria

* The first dose of sorafenib 7 days after the 3nd TACE procedure
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , China

Site Status

Countries

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China

Other Identifiers

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NX1216CN

Identifier Type: OTHER

Identifier Source: secondary_id

16608

Identifier Type: -

Identifier Source: org_study_id