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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Procedure: Transarterial Chemoembolization (TACE) Other: Sorafenib in combination with TACE Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Study Start Date : May 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group TACE
Patients who undergo TACE
 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 .
Experimental: Group Combination
Patients who are treated with sorafenib combined with TACE
 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)


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE) [ Time Frame: 1 year ]
    Measure:time-to-proression


Secondary Outcome Measures :
  1. 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)

  2. Survival in the two treatment groups [ Time Frame: 2 years ]
    Measured from the date of TACE until the date of death or last visit


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556815


Contacts
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Contact: Jinlong Song, MD +8653167626411 songjlmd@gmail.com

Locations
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China, Shandong
Shandong Cancer Hospital and Institute Not yet recruiting
Jinan, Shandong, China, 250117
Contact: Wenbo Shao, MD, Ph D    +8653167626412    shaowenbomd@gmail.com   
Principal Investigator: Jinlong Song, MD         
Sub-Investigator: Wenbo Shao, MD, Ph D         
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
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Principal Investigator: Jinlong Song, MD Shandong Cancer Hospital and Institute
More Information
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Responsible Party: Jinlong Song, Chief, Division of Interventional Therapy, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01556815     History of Changes
Other Study ID Numbers: ShandongCHI-001
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012

Keywords provided by Jinlong Song, Shandong Cancer Hospital and Institute:
Hepatocellular Carcinoma
Sorafenib
Transarterial Chemoembolization
HBV

Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Adenocarcinoma
Carcinoma, Hepatocellular
Liver Diseases
Liver Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Digestive System Diseases
Gastrointestinal Diseases
 Sorafenib
Chlorotrianisene
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal