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

Phase 1
18 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

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

Inclusion Criteria:

- Patients with inoperable HCC, who are candidates for transarterial chemoembolization

- 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

- Congestive heart failure, serious cardiac arrhythmia, active coronary artery

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

To assess the safety and tolerability of the administration of sorafenib in patients with hepatocellular carcinoma treated with TACE by determining the MTD.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Daniel Candinas

Investigator Role:

Principal Investigator

Investigator Affiliation:



Switzerland: Swissmedic

Study ID:




Start Date:

May 2007

Completion Date:

January 2009

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular