Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

NCT ID: NCT01932385

Last Updated: 2018-02-14

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

Clinical Phase

PHASE2/PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-01

Study Completion Date

2016-07-30

Brief Summary

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Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.

Detailed Description

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Conditions

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Liver Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sorafenib

sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.

Group Type EXPERIMENTAL

Sorafenib

Intervention Type DRUG

Best Supportive Care

Intervention Type OTHER

Best Supportive Care

treatment mainly on nutrition and symptoms control

Group Type ACTIVE_COMPARATOR

Best Supportive Care

Intervention Type OTHER

Interventions

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Sorafenib

Intervention Type DRUG

Best Supportive Care

Intervention Type OTHER

Other Intervention Names

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Nexavar

Eligibility Criteria

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Inclusion Criteria

* pathological or cytological confirmed advanced hepatocellular carcinoma
* 18 years to 80 years
* liver function Child-Pugh class B
* BCLC stage B or C
* estimated life time 2 months or longer

Exclusion Criteria

* previous target therapy
* allergy to Sorafenib
* Uncontrolled Bleeding or diarrhea
* eligible for locoregional treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingdao Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Youxin Ji

Chief, Department of Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ketao lan, M.D.

Role: STUDY_DIRECTOR

Qingdao Health Bereau

Locations

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Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, China

Site Status

Countries

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China

Other Identifiers

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QCH20130823

Identifier Type: -

Identifier Source: org_study_id

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