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Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT01932385
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Youxin Ji, Qingdao Central Hospital

Tracking Information
First Submitted Date  ICMJE August 22, 2013
First Posted Date  ICMJE August 30, 2013
Last Update Posted Date February 14, 2018
Study Start Date  ICMJE August 1, 2013
Actual Primary Completion Date January 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01932385 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
response rate [ Time Frame: every 4 weeks till progression, total up to 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
Official Title  ICMJE Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Cancer
Intervention  ICMJE
  • Drug: Sorafenib
    Other Name: Nexavar
  • Other: Best Supportive Care
Study Arms  ICMJE
  • Experimental: sorafenib
    sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.
    Interventions:
    • Drug: Sorafenib
    • Other: Best Supportive Care
  • Active Comparator: Best Supportive Care
    treatment mainly on nutrition and symptoms control
    Intervention: Other: Best Supportive Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2018)
86
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2013)
90
Actual Study Completion Date  ICMJE July 30, 2016
Actual Primary Completion Date January 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01932385
Other Study ID Numbers  ICMJE QCH20130823
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Youxin Ji, Qingdao Central Hospital
Study Sponsor  ICMJE Qingdao Central Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ketao lan, M.D. Qingdao Health Bereau
PRS Account Qingdao Central Hospital
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP