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Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma

Phase 2
18 Years
80 Years
Not Enrolling
PHENYTOIN/SORAFENIB [VA Drug Interaction], Liver Neoplasms, Carcinoma, Hepatocellular, Digestive System Neoplasms, Neoplasms by Site, Liver Diseases, Adenocarcinoma, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction], HBV

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Trial Information

Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma

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

- 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

- 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

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:

Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)

Outcome Description:


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:

May 2012

Completion Date:

May 2015

Related Keywords:

  • PHENYTOIN/SORAFENIB [VA Drug Interaction]
  • Liver Neoplasms
  • Carcinoma, Hepatocellular
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Liver Diseases
  • Adenocarcinoma
  • Carcinoma
  • Neoplasms, Glandular and Epithelial
  • Neoplasms by Histologic Type
  • HBV
  • Hepatocellular Carcinoma
  • Sorafenib
  • Transarterial Chemoembolization
  • HBV
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Carcinoma
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms
  • Liver Diseases
  • Liver Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neoplasms, Glandular and Epithelial
  • Carcinoma, Hepatocellular