Sorafenib With TACE to Treat Hepatocellular Carcinoma (S-TACE)

November 1, 2010 updated by: University of Bern

Transarterial Chemoembolisation With Doxorubicin in Combination With Systemic Administration of Sorafenib for Patients With Hepatocellular Carcinoma

The purpose of this study is to determine the feasibility to combine sorafenib with transarterial chemoembolisation in patients suffering from hepatocellular carcinoma.The hypothesis is that sorafenib may prevent the development and growth of tumoral lesions not treated by chemoembolisation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

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:

  • Patients with inoperable HCC, who are candidates for transarterial chemoembolization (TACE).
  • Diagnosis of hepatocellular carcinoma based on the EASL's criteria (1).
  • Child-Pugh score < 10 (Child A or B),
  • Life expectancy superior to 12 weeks at the pre-treatment evaluation.
  • Local therapies have been interrupted for at least 4 weeks
  • Written informed consent signed
  • Age >= 18
  • Performance status ECOG 0-1

  • Normal organ and marrow function defined as:

    • Haematopoietic: absolute neutrophil count >1,500/mm3, platelet count > 60,000/mm3, haemoglobin > 9g/dL
    • INR < 1.5 ULN and PTT within normal limits
    • Hepatic: AST or ALT < 5 x ULN
    • Renal: creatinine < 1.5 x ULN
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Women of childbearing potential and men must agree to use adequate birth contraception (must be double and methods recorded) prior to study entry and for the duration of the study participation. For both men and women, these adequate birth control measures must be used for at least 3 months after the last administration of study drug.

Exclusion Criteria:

  • Active heart disease is defined as congestive heart failure >NYHA (New York Heart Association) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted) or uncontrolled hypertension.

    • Congestive heart failure, serious cardiac arrhythmia, active coronary artery disease.
    • Thrombotic or embolic events within the past 6 months such as a cerebrovascular accident (including transient ischemic attacks), pulmonary embolism.
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
    • Psychiatric illness/social situations that would limit compliance with study requirements.
    • Patients with evidence of active infection will become eligible for reconsideration 7 days after completing antibiotic therapy.
    • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib.
    • Patients who have been treated with sorafenib.
    • Cerebral metastasis.
    • Child-Pugh score C.
    • Hypertension defined as systolic blood pressure greater than 150 mmHg or diastolic pressure greater than 90 mmHg despite optimal medical management.
    • Proteinuria defined as a 24-hour urine protein excretion greater than 1000 mg. Urine dipstick proteinuria of 1+ or greater will require a 24-hour urine to determine eligibility for enrolment.
    • Therapeutic anticoagulation with coumarin, heparins, or heparinoids.
    • Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months of fracture.
    • Evidence of bleeding diathesis.
    • Impairment of swallowing that would preclude administration of sorafenib.
    • History of haemoptysis or surgery within the past 28 days.
    • Organ allograft.
    • Pregnant or breastfeeding patients.

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Sorafenib
Sorafenib 400mg bid
Procedure: Transarterial chemoembolisation with doxorubicin
Transarterial chemoembolisation (TACE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of the administration of sorafenib in patients with hepatocellular carcinoma treated with TACE by determining the MTD.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
tumor volumetry
Time Frame: 2 years
2 years
changes in the blood concentration of tumor marker AFP
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

University of Bern

Investigators

  • Principal Investigator: Daniel Candinas, Inselspital
  • Principal Investigator: Markus Borner, Inselspital
  • Study Director: Jean-François J Dufour, MD, Inselspital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

May 23, 2007

First Submitted That Met QC Criteria

May 23, 2007

First Posted (Estimate)

May 24, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JFD-12581

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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