TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

Shandong First Medical University

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Hepatocellular; PHENYTOIN/SORAFENIB [VA Drug Interaction]

Treatments: Drug: sorafenib combined with TACE; Procedure: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT01605734

ShandongCHI-002

Details and patient eligibility

About

TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 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 or C
• Child-Pugh class score≤8
• ECOG performance status ≤2
• 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 18-75 years
• Haematology:Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 50 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
• Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)< 5 x the upper limit of normal,Total bilirubin < 3 x the upper limit of normal,Serum creatinine < 1.5 x the upper limit of normal,Cholinesterase>0.5x the lower limit of normal，Prealbumin>0.5x the lower limit of normal.
• Life expectancy of > 3 months

Exclusion criteria

• BCLC stage D
• Child-Pugh Score≥9
• Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
• Preexisting or history of hepatic encephalopathy
• uncontrolled hypertension
• Pregnancy (positive serum pregnancy test) or lactation
• 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
• Other severe concomitant disease that may reduce life expectancy
• Risk of allergic reactions to the study drugs
• Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Group TACE

Active Comparator group

Description:

TACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated if clinically indicated

Treatment:

Procedure: TACE

Group Combination

Experimental group

Description:

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

Treatment:

Drug: sorafenib combined with TACE