Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2012
CompletedFirst Posted
Study publicly available on registry
March 16, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedApril 25, 2012
April 1, 2012
2 years
March 14, 2012
April 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
Measure:time-to-proression
1 year
Secondary Outcomes (2)
safety of sorafenib in combination with TACE
6 months
Survival in the two treatment groups
2 years
Study Arms (2)
Group TACE
ACTIVE COMPARATORPatients who undergo TACE
Group Combination
EXPERIMENTALPatients who are treated with sorafenib combined 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 .
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 .
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinlong Song, MD
Shandong Cancer Hospital and Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Division of Interventional Therapy
Study Record Dates
First Submitted
March 14, 2012
First Posted
March 16, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2015
Last Updated
April 25, 2012
Record last verified: 2012-04