Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Information source: Shandong Cancer Hospital and Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 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
Intervention: Transarterial Chemoembolization (TACE) (Procedure); Sorafenib in combination with TACE (Other)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Shandong Cancer Hospital and Institute Official(s) and/or principal investigator(s): Jinlong Song, MD, Principal Investigator, Affiliation: Shandong Cancer Hospital and Institute
Overall contact: Jinlong Song, MD, Phone: +8653167626411, Email: songjlmd@gmail.com
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.
Clinical Details
Official title: Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
Secondary outcome: safety of sorafenib in combination with TACESurvival in the two treatment groups
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): 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
Locations and Contacts
Jinlong Song, MD, Phone: +8653167626411, Email: songjlmd@gmail.com
Shandong Cancer Hospital and Institute, Jinan, Shandong 250117, China; Not yet recruiting Wenbo Shao, MD, Ph D, Phone: +8653167626412, Email: shaowenbomd@gmail.com Jinlong Song, MD, Principal Investigator Wenbo Shao, MD, Ph D, Sub-Investigator
Additional Information
Starting date: May 2012
Last updated: April 24, 2012
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