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Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

Sponsor
Qingdao Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01932385
Collaborator
(none)
86
Enrollment
1
Location
2
Arms
35.9
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Jan 30, 2016
Actual Study Completion Date :
Jul 30, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. progression free survival and overall survival [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

    1. response rate [every 4 weeks till progression, total up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qingdao Central Hospital, Qingdao Cancer Hospital Qingdao Shandong China 266042

    Sponsors and Collaborators

    • Qingdao Central Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Youxin Ji, Chief, Department of Oncology, Qingdao Central Hospital
    ClinicalTrials.gov Identifier:
    NCT01932385
    Other Study ID Numbers:
    • QCH20130823
    First Posted:
    Aug 30, 2013
    Last Update Posted:
    Feb 14, 2018
    Last Verified:
    Oct 1, 2015
    Keywords provided by Youxin Ji, Chief, Department of Oncology, Qingdao Central Hospital
    Sorafenib
    Hepatocellular carcinoma
    Best supportive care
    Survival
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Sorafenib

    Study Results

    No Results Posted as of Feb 14, 2018