Trial of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib for Locally Advanced Hepatocellular Carcinoma (HCC)

June 22, 2011 updated by: Chung-Ang University

Phase II Trial of TACE With Sorafenib in Patients With Locally Advanced Hepatocellular Carcinoma

To evaluate the time to progression of the combination therapy of Transcatheter Arterial Chemoembolization (TACE) and sorafenib in patients with previously untreated advanced or metastatic hepatocellular carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

63

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

  • Name: Joung-Soon Jang, M.D.
  • Phone Number: 82-2-6299-1427
  • Email: alsaba@daum.net

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Seoul
      • Dongjak, Seoul, Korea, Republic of, 156-755
        • Recruiting
        • Chung-Ang University Hospital
        • Contact:
          • Joung-Soon Jang, M.D.
          • Phone Number: 82-2-6299-1427
          • Email: alsaba@daum.net
        • Contact:
        • Principal Investigator:
          • Joung-Soon Jang, M.D.
        • Sub-Investigator:
          • Hyung Joon Kim, M.D.
        • Sub-Investigator:
          • Hyun Woong Lee, M.D.
        • Sub-Investigator:
          • In Gyu Hwang, M.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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Unresectable Hepatocellular carcinoma with local liver lesion treatable with TACE
  2. Age > 18 years.
  3. ECOG Performance Status of 0 or 1.
  4. Child-Pugh class A (class B could be included when Childs score is 7).
  5. Life expectancy of at least 12 weeks.
  6. Subjects with at least one measurable lesion.

  7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

    • Hemoglobin > 9.0 g/dl
    • Absolute neutrophil count (ANC) >1,500/mm3
    • Platelet count > 75,000/μl
    • Total bilirubin < 1.5 times the upper limit of normal
    • ALT and AST < 2.5 x upper limit of normal (UNL)
    • Alkaline phosphatase < 5 x ULN
    • PT-INR/PTT < 1.5 x upper limit of normal
    • Serum creatinine < 1.5 x ULN
  8. Signed and dated informed consent before the start of specific protocol procedures

Exclusion Criteria:

  1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension.
  2. History of HIV infection.
  3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  4. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
  5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
  6. History of organ allograft The organ allograft may be allowed as protocol specific.
  7. Patients with evidence or history of uncontrolled bleeding diathesis
  8. Patients undergoing renal dialysis
  9. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.

  10. Excluded therapies and medications, previous and concomitant:

    • Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
    • Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study
    • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    • Prior exposure to the study drug.
    • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication).
    • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
    • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
    • Patients unable to swallow oral medications

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: 2 year
Assessments including image and laboratory studies will take place within 7days of the every TACE cycle
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the toxicity profiles
Time Frame: 2 year
Clinically assessed every TACE cycle
2 year

Collaborators and Investigators

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

Sponsor

Chung-Ang University

Collaborators

Gyeongsang National University Hospital

Investigators

  • Principal Investigator: Joung-Soon Jang, M.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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

June 1, 2009

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAUHHO 2009-1

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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