Sorafenib and Transarterial Chemoembolization for Hepatocellular Carcinoma

NCT00768937 | Completed Phase 1

• 1 other identifier: SORATACE1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) as the third most common cause of cancer-related death has a very poor prognosis. Aim of this open label single arm non randomized pilot trial is the evaluation of the efficacy and safety of sorafenib in combination with TACE in patients with unresectable HCC. Efficacy ad safety will be compared with a historical TACE-only group of a placebo controlled TACE-trial.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; sorafenib; transarterial chemoembolization; tumor angiogenesis; angiogenic factors

Outcome Measures

Primary Outcomes (2)

• Time to Progression (Efficacy)

  Until disease progression

• Safety of Sorafenib in combination with TACE

  Continuously until 12 weeks after the last TACE

Study Arms (1)

Treatment arm

EXPERIMENTAL

all patients will be treated with sorafenib

Drug: Sorafenib; Procedure: Transarterial chemoembolisation (TACE)

Interventions

Sorafenib DRUG

All patients will receive Sorafenib (800 mg/day) p.o. beginning two weeks before the first TACE and every day thereafter until patient death or premature withdrawal from study.

Also known as: Nexavar (brand name)

Treatment arm

Transarterial chemoembolisation (TACE) PROCEDURE

TACE will be carried out with doxorubicin (75 - 50 - 25 mg/m2, depending on serum bilirubin levels ≤ 1.5, 1.5 - 3, 3 - 5 mg/dL) : lipiodol (1:1) in a total volume of 20 mL; after administration of doxorubicin:lipiodol, additional embolisation will be carried out with bead block-endospheres. TACE will be repeated every 4 weeks for 3 cycles; additional cycles will be offered if clinically indicated (but no PEI or RF-ablation should be carried out after inclusion into the study)

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed HCC not suitable for OLT or resection ( \> 3 nodules, \>5 cm diameter, vascular invasion, clinically significant portal hypertension, other contraindications against OLT)
• Child-Pugh Stage A or B
• Liver disease of any etiology
• Written informed consent (approved by the Institutional Review Board \[IRB\]/Independent Ethics Committee \[IEC\]) obtained prior to any study specific screening procedures
• Patient must be able to comply with the protocol
• Age ≥ 18 years
• Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the Sorafenib.
• Fertile women and men of childbearing potential ( \< 2 years after last menstruation in women) must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
• Haematology:
• Absolute neutrophil count (ANC) \> 1 x 109/L Platelet count \> 40 x 109/L Haemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time ≥ 40%
• Biochemistry:
• Total bilirubin \< 5 mg/dL Serum creatinine \< 3.0 mg/dL
• Life expectancy of \> 3 months

You may not qualify if:

• Extrahepatic tumor spread
• Complete portal vein thrombosis (common trunk)
• Child-Pugh-Stage C
• Prior TACE or TAE
• Other experimental therapies for HCC
• Acute variceal bleeding within the last 2 weeks
• Large oesophageal varices ( \> 5 mm diameter) without prophylactic band ligation
• Past or current history (within the last 2 years prior to randomisation) of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
• History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke within \< 6 months), excluding hepatic encephalopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study
• Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants for therapeutic purposes
• Chronic, daily treatment with aspirin (\>325mg/day)
• Pregnancy (positive serum pregnancy test) or lactation
• Uncontrolled hypertension
• Serious, non-healing wound, ulcer, or bone fracture

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Abteilung Gastroenterologie und Hepatologie, Medizinische Universität und AKH Wien

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Markus Peck-Radosavljevic, Prof. Dr.

  Abteilung Gastroenterologie und Hepatologie, Medizinische Universität und AKH Wien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 8, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 9, 2010

Record last verified: 2010-11

Locations

AU (1)