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

Shandong First Medical University

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Hepatocellular; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Carcinoma; Digestive System Neoplasms; HBV; Adenocarcinoma; Neoplasms by Histologic Type; Liver Neoplasms; PHENYTOIN/SORAFENIB [VA Drug Interaction]; DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction]; Liver Diseases

Treatments: Procedure: Transarterial Chemoembolization (TACE); Other: Sorafenib in combination with TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT01556815

ShandongCHI-001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group TACE

Active Comparator group

Description:

Patients who undergo TACE

Treatment:

Procedure: Transarterial Chemoembolization (TACE)

Group Combination

Experimental group

Description:

Patients who are treated with sorafenib combined with TACE

Treatment:

Other: Sorafenib in combination with TACE