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

April 24, 2012 updated by: Jinlong Song, Shandong Cancer Hospital and Institute

Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital and Institute
        • Contact:
        • Principal Investigator:
          • Jinlong Song, MD
        • Sub-Investigator:
          • Wenbo Shao, MD, Ph D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Sorafenib:Nexavar(brand name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
Time Frame: 1 year
Measure:time-to-proression
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months
Survival in the two treatment groups
Time Frame: 2 years
Measured from the date of TACE until the date of death or last visit
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Investigators

  • Principal Investigator: Jinlong Song, MD, Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

March 14, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (Estimate)

March 16, 2012

Study Record Updates

Last Update Posted (Estimate)

April 25, 2012

Last Update Submitted That Met QC Criteria

April 24, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShandongCHI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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