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

Primary Purpose

PHENYTOIN/SORAFENIB [VA Drug Interaction], Liver Neoplasms, Carcinoma, Hepatocellular

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Transarterial Chemoembolization (TACE)
Sorafenib in combination with TACE
Sponsored by
Shandong Cancer Hospital and Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PHENYTOIN/SORAFENIB [VA Drug Interaction] focused on measuring Hepatocellular Carcinoma, Sorafenib, Transarterial Chemoembolization, HBV

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shandong Cancer Hospital and Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group TACE

Group Combination

Arm Description

Patients who undergo TACE

Patients who are treated with sorafenib combined with TACE

Outcomes

Primary Outcome Measures

Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
Measure:time-to-proression

Secondary Outcome Measures

safety of sorafenib in combination with TACE
Measure: incidence and grade of adverse events in patients treated with sorafenib combined with TACE (group B)
Survival in the two treatment groups
Measured from the date of TACE until the date of death or last visit

Full Information

First Posted
March 14, 2012
Last Updated
April 24, 2012
Sponsor
Shandong Cancer Hospital and Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01556815
Brief Title
Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Official Title
Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Cancer Hospital and Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Hepatocellular Carcinoma, Sorafenib, Transarterial Chemoembolization, HBV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group TACE
Arm Type
Active Comparator
Arm Description
Patients who undergo TACE
Arm Title
Group Combination
Arm Type
Experimental
Arm Description
Patients who are treated with sorafenib combined with TACE
Intervention Type
Procedure
Intervention Name(s)
Transarterial Chemoembolization (TACE)
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
Sorafenib in combination with TACE
Other Intervention Name(s)
Sorafenib:Nexavar(brand name)
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)
Description
Measure:time-to-proression
Time Frame
1 year
Secondary Outcome Measure Information:
Title
safety of sorafenib in combination with TACE
Description
Measure: incidence and grade of adverse events in patients treated with sorafenib combined with TACE (group B)
Time Frame
6 months
Title
Survival in the two treatment groups
Description
Measured from the date of TACE until the date of death or last visit
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinlong Song, MD
Phone
+8653167626411
Email
songjlmd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinlong Song, MD
Organizational Affiliation
Shandong Cancer Hospital and Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong Cancer Hospital and Institute
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbo Shao, MD, Ph D
Phone
+8653167626412
Email
shaowenbomd@gmail.com
First Name & Middle Initial & Last Name & Degree
Jinlong Song, MD
First Name & Middle Initial & Last Name & Degree
Wenbo Shao, MD, Ph D

12. IPD Sharing Statement

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

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