Sorafenib With TACE to Treat Hepatocellular Carcinoma
S-TACE
Transarterial Chemoembolisation With Doxorubicin in Combination With Systemic Administration of Sorafenib for Patients With Hepatocellular Carcinoma
1 other identifier
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hepatocellular-carcinoma
Started May 2007
Shorter than P25 for phase_1 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 23, 2007
CompletedFirst Posted
Study publicly available on registry
May 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedNovember 2, 2010
November 1, 2010
1.7 years
May 23, 2007
November 1, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
tumor volumetry
2 years
changes in the blood concentration of tumor marker AFP
2 years
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inselspital
Bern, Canton of Bern, 3010, Switzerland
Related 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 a phase I study. Oncologist. 2010;15(11):1198-204. doi: 10.1634/theoncologist.2010-0180. Epub 2010 Oct 29.
PMID: 21036880RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Candinas
Inselspital
- PRINCIPAL INVESTIGATOR
Markus Borner
Inselspital
- STUDY DIRECTOR
Jean-François J Dufour, MD
Inselspital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 23, 2007
First Posted
May 24, 2007
Study Start
May 1, 2007
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
November 2, 2010
Record last verified: 2010-11