Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

February 13, 2018 updated by: Youxin Ji, Qingdao Central Hospital

Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266042
        • Qingdao Central Hospital, Qingdao Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sorafenib
sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.
Drug: Sorafenib
Other Names:
  • Nexavar
Other: Best Supportive Care
Active Comparator: Best Supportive Care
treatment mainly on nutrition and symptoms control
Other: Best Supportive Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival and overall survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause up to 12 months
From date of randomization until the date of first documented progression or date of death from any cause up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: every 4 weeks till progression, total up to 12 months
every 4 weeks till progression, total up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao Central Hospital

Investigators

  • Study Director: ketao lan, M.D., Qingdao Health Bereau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

January 30, 2016

Study Completion (Actual)

July 30, 2016

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QCH20130823

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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