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Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT01556815
Recruitment Status : Unknown
Verified April 2012 by Jinlong Song, Shandong Cancer Hospital and Institute.
Recruitment status was:  Not yet recruiting
First Posted : March 16, 2012
Last Update Posted : April 25, 2012
Sponsor:
Information provided by (Responsible Party):
Jinlong Song, Shandong Cancer Hospital and Institute

Tracking Information
First Submitted Date  ICMJE March 14, 2012
First Posted Date  ICMJE March 16, 2012
Last Update Posted Date April 25, 2012
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE) [ Time Frame: 1 year ]
Measure:time-to-proression
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • safety of sorafenib in combination with TACE [ Time Frame: 6 months ]
    Measure: incidence and grade of adverse events in patients treated with sorafenib combined with TACE (group B)
  • Survival in the two treatment groups [ Time Frame: 2 years ]
    Measured from the date of TACE until the date of death or last visit
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 Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Official Title  ICMJE Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Brief Summary Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • PHENYTOIN/SORAFENIB [VA Drug Interaction]
  • Liver Neoplasms
  • Carcinoma, Hepatocellular
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Liver Diseases
  • Adenocarcinoma
  • Carcinoma
  • Neoplasms, Glandular and Epithelial
  • Neoplasms by Histologic Type
  • DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction]
  • HBV
Intervention  ICMJE
  • Procedure: Transarterial Chemoembolization (TACE)
    Procedure:TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .
  • Other: Sorafenib in combination with TACE

    Drug: Sorafenib All patients will receive Sorafenib (800 mg/day) p.o. beginning one week after the first TACE and every day thereafter until patient death or premature withdrawal from study.

    Procedure: TACE

    TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .

    Other Name: Sorafenib:Nexavar(brand name)
Study Arms  ICMJE
  • Active Comparator: Group TACE
    Patients who undergo TACE
    Intervention: Procedure: Transarterial Chemoembolization (TACE)
  • Experimental: Group Combination
    Patients who are treated with sorafenib combined with TACE
    Intervention: Other: Sorafenib in combination with TACE
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 15, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2015
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
  • BCLC stage B
  • Child-Pugh class A
  • ECOG performance status of 0
  • Etiology: Hepatitis B virus(HBV) infection
  • Written informed consent (approved by the Institutional Review Board [IRB]obtained prior to any study specific screening procedures
  • Patient must be able to comply with the protocol
  • Age 18-80 years
  • Haematology:Absolute neutrophil count (ANC) > 1 x 109/L, Platelet count > 40 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
  • Biochemistry:Total bilirubin < 2 mg/dL Serum creatinine < 1.5 x the upper limit of normal
  • Life expectancy of > 3 months

Exclusion Criteria:

  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x the upper limit of normal
  • Other severe concomitant disease that may reduce life expectancy
  • uncontrolled hypertension
  • Pregnancy (positive serum pregnancy test) or lactation
  • Uncontrolled hypertension
  • Serious, non-healing wound, ulcer, or bone fracture
  • Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
  • Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
  • Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications
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 NCT01556815
Other Study ID Numbers  ICMJE ShandongCHI-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jinlong Song, Shandong Cancer Hospital and Institute
Study Sponsor  ICMJE Shandong Cancer Hospital and Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jinlong Song, MD Shandong Cancer Hospital and Institute
PRS Account Shandong Cancer Hospital and Institute
Verification Date April 2012

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