TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute
• Treatments: Chlorotrianisene; Niacinamide; Sorafenib

Criteria

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