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

Phase 2
18 Years
75 Years
Not Enrolling
PHENYTOIN/SORAFENIB [VA Drug Interaction], Carcinoma, Hepatocellular

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Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression

Outcome Description:

Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Jinlong Song, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shandong Cancer Hospital and Institute


China: Ministry of Health

Study ID:




Start Date:

July 2012

Completion Date:

December 2015

Related Keywords:

  • PHENYTOIN/SORAFENIB [VA Drug Interaction]
  • Carcinoma, Hepatocellular
  • hepatocellular carcinoma
  • transarterial chemoembolization
  • sorafenib
  • Carcinoma
  • Carcinoma, Hepatocellular