Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma

Phase 2

• Conditions: PHENYTOIN/SORAFENIB [VA Drug Interaction]; Liver Neoplasms; Carcinoma, Hepatocellular; Digestive System Neoplasms; Neoplasms by Site; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type
• Interventions: Procedure: Transarterial Chemoembolization (TACE); Other: Sorafenib in combination with TACE

• Registration Number: NCT01556815
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief Summary

Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-16
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25
• Study Start: 2012-05
• Primary Completion: 2014-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
• BCLC stage B
• Child-Pugh class A
• ECOG performance status of 0
• Etiology: Hepatitis B virus(HBV) infection
• Written informed consent (approved by the Institutional Review Board [IRB]obtained prior to any study specific screening procedures
• Patient must be able to comply with the protocol
• Age 18-80 years
• 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 international normalized ratio < 1.5
• Biochemistry:Total bilirubin < 2 mg/dL Serum creatinine < 1.5 x the upper limit of normal
• Life expectancy of > 3 months

Exclusion Criteria

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x the upper limit of normal
• Other severe concomitant disease that may reduce life expectancy
• uncontrolled hypertension
• Pregnancy (positive serum pregnancy test) or lactation
• Uncontrolled hypertension
• Serious, non-healing wound, ulcer, or bone fracture
• Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
• Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
• Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TACE	Transarterial Chemoembolization (TACE)	Patients who undergo TACE
Group Combination	Sorafenib in combination with TACE	Patients who are treated with sorafenib combined with TACE

Primary Outcome Measures

Name	Time	Method
Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)	1 year	Measure:time-to-proression

Secondary Outcome Measures

Name	Time	Method
safety of sorafenib in combination with TACE	6 months	Measure: incidence and grade of adverse events in patients treated with sorafenib combined with TACE (group B)
Survival in the two treatment groups	2 years	Measured from the date of TACE until the date of death or last visit

Trial Locations

Locations (1)

Shandong Cancer Hospital and Institute; 🇨🇳 Jinan, Shandong, China