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ClinicalTrials.gov ID

NCT01605734

Lead Sponsor

Shandong Cancer Hospital and InstituteOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

120Estimated

Last Update Posted

May 25, 2012Estimated

Start Date

Jul 2012

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2015Estimated

Official Title

Phase II Trail of TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

Brief 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.

• PHENYTOIN/SORAFENIB [VA Drug Interaction]
• Carcinoma, Hepatocellular

• TACE
• sorafenib combined with TACE

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Shandong Cancer Hospital and InstituteOTHER

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