TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

This study is not yet open for participant recruitment.
Verified May 2012 by Shandong Cancer Hospital and Institute
Sponsor:
Information provided by (Responsible Party):
Jinlong Song, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01605734
First received: May 11, 2012
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.


Condition Intervention Phase
PHENYTOIN/SORAFENIB [VA Drug Interaction]
Carcinoma, Hepatocellular
Procedure: TACE
Drug: sorafenib combined with TACE
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trail of TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Shandong Cancer Hospital and Institute:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week


Secondary Outcome Measures:
  • FACT-Hep [ Time Frame: six months ] [ Designated as safety issue: No ]
    FACT-Hep is a chart established to evaluate the life quality of patients with HCC every 4 weeks

  • Disease control rate [ Time Frame: six months after TACE ] [ Designated as safety issue: No ]
    CR+PR+SD

  • Safety [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)

  • PFS and OS [ Time Frame: two years ] [ Designated as safety issue: No ]
    The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively

  • Number of TACE sessions and the interval time between two TACE sessions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • AFP [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group TACE
TACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated if clinically indicated
Procedure: TACE
After obtaining arterial access,a diagnostic visceral arteriogram will be performed to demonstrate arterial supply to the tumor and the presence of variant arterial anatomy.After having positioned the catheter within the artery feeding tumor,the chemoembolization mixture will be infused into th e artery until stagnant flow is observed.
Experimental: Group Combination
All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study
Drug: sorafenib combined with TACE
All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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 or C
  • Child-Pugh class score≤8
  • ECOG performance status ≤2
  • 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 18-75 years
  • Haematology:Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 50 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
  • Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)< 5 x the upper limit of normal,Total bilirubin < 3 x the upper limit of normal,Serum creatinine < 1.5 x the upper limit of normal,Cholinesterase>0.5x the lower limit of normal,Prealbumin>0.5x the lower limit of normal.
  • Life expectancy of > 3 months

Exclusion Criteria:

  • BCLC stage D
  • Child-Pugh Score≥9
  • Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
  • Preexisting or history of hepatic encephalopathy
  • uncontrolled hypertension
  • Pregnancy (positive serum pregnancy test) or lactation
  • 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
  • Other severe concomitant disease that may reduce life expectancy
  • Risk of allergic reactions to the study drugs
  • Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605734

Contacts
Contact: Jinlong Song, MD +8653167626411 songjlmd@gmail.com
Contact: Wenbo Shao, MD,Ph D +8653167626412 shaowenbomd@gmai.com

Locations
China, Shandong
Shandong Medical Imaging Research Institute Not yet recruiting
Jinan, Shandong, China, 250021
Contact: Jun Tang, MD    +8613964031909    tangjun7925032@163.com   
Principal Investigator: Jun Tang, MD         
Qilu Hospital of Shandong University Not yet recruiting
Jinan, Shandong, China, 250114
Contact: Caixia Li, MD    +8613505312972    Lilyshanda88@hotmail.com   
Principal Investigator: Caixia Li, MD         
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117
the Affiliated Hospital of Medical College Qingdao University Not yet recruiting
Qingdao, Shandong, China, 266003
Contact: Zixiang Li, MD    +8618669739263    zixiangli@yahoo.com.cn   
Principal Investigator: Zixiang Li, MD         
Yantai Yuhuangding Hospital Not yet recruiting
Yantai, Shandong, China, 264000
Contact: Yanbo Zheng, MD    +8613805356068    13805356068@163.com   
Principal Investigator: Yanbo Zheng         
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
Principal Investigator: Jinlong Song, MD Shandong Cancer Hospital and Institute
  More Information

No publications provided

Responsible Party: Jinlong Song, Chief, Division of Interventiolal Therapy, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01605734     History of Changes
Other Study ID Numbers: ShandongCHI-002
Study First Received: May 11, 2012
Last Updated: May 21, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shandong Cancer Hospital and Institute:
hepatocellular carcinoma
transarterial chemoembolization
sorafenib

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014