Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01556815
• Other study ID #: ShandongCHI-001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 14, 2012
• Last updated: April 24, 2012
• Start date: May 2012
• Est. completion date: May 2015

Study information

• Verified date: April 2012
• Source: Shandong Cancer Hospital and Institute
• Contact: Jinlong Song, MD
• Phone: +8653167626411
• Email: songjlmd[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Transarterial Chemoembolization (TACE)
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 .

Other:
• Sorafenib 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 .

Locations

Country	Name	City	State
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)	Measure:time-to-proression	1 year	No
Secondary	safety of sorafenib in combination with TACE	Measure: incidence and grade of adverse events in patients treated with sorafenib combined with TACE (group B)	6 months	Yes
Secondary	Survival in the two treatment groups	Measured from the date of TACE until the date of death or last visit	2 years	No