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
Keywords
Hepatocellular Carcinoma, Sorafenib, Transarterial Chemoembolization, HBV
Brief 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.
Interventions
Procedure:TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .
OTHERSorafenib in combination with TACE
Drug: Sorafenib All patients will receive Sorafenib (800 mg/day) p.o. beginning one week after the first TACE and every day thereafter until patient death or premature withdrawal from study. Procedure: TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE) | 1 year | Measure:time-to-proression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of sorafenib in combination with TACE | 6 months | Measure: incidence and grade of adverse events in patients treated with sorafenib combined with TACE (group B) |
| Survival in the two treatment groups | 2 years | Measured from the date of TACE until the date of death or last visit |
Countries
China
Contacts
Primary ContactJinlong Song, MD
Outcome results
None listed