Sorafenib With TACE to Treat Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— S-TACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478374
• Other study ID #: JFD-12581
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2007
• Last updated: November 1, 2010
• Start date: May 2007
• Est. completion date: January 2009

Study information

• Verified date: November 2010
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sorafenib
Sorafenib 400mg bid

Procedure:
• Transarterial chemoembolisation with doxorubicin
Transarterial chemoembolisation (TACE)

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Dufour JF, Hoppe H, Heim MH, Helbling B, Maurhofer O, Szucs-Farkas Z, Kickuth R, Borner M, Candinas D, Saar B. Continuous administration of sorafenib in combination with transarterial chemoembolization in patients with hepatocellular carcinoma: results of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of the administration of sorafenib in patients with hepatocellular carcinoma treated with TACE by determining the MTD.		2 years	Yes
Secondary	tumor volumetry		2 years	No
Secondary	changes in the blood concentration of tumor marker AFP		2 years	No