Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Conditions
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
Conditions: official terms
Adenocarcinoma - Carcinoma - Carcinoma, Hepatocellular - Digestive System Neoplasms - Gastrointestinal Neoplasms - Liver Diseases - Liver Neoplasms - Neoplasms - Neoplasms by Histologic Type - Neoplasms by Site - Neoplasms, Glandular and Epithelial
Conditions: Keywords
Hepatocellular Carcinoma, Sorafenib, Transarterial Chemoembolization, HBV
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Transarterial Chemoembolization (TACE) Type: Procedure
Name: Sorafenib in combination with TACE Type: Other
Overall Status
Not yet recruiting
Summary
Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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 normal

- 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 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
Location
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Status: Not yet recruiting
Contact: Wenbo Shao, MD, Ph D - +8653167626412 - shaowenbomd@gmail.com
Start Date
May 2012
Completion Date
May 2015
Sponsors
Shandong Cancer Hospital and Institute
Source
Shandong Cancer Hospital and Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page