Sorafenib Combined With Transarterial Chemoembolization i... | NCT01556815

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

NCT01556815

Sponsor

Shandong Cancer Hospital and Institute

Status

Unknown status

Last Update Posted

Apr 25, 2012Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

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

Interventions

Transarterial Chemoembolization (TACE)
Sorafenib in combination with TACE

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

May 2014Estimated

Completion Date

May 2015Estimated

First Submitted Date

Mar 14, 2012

First Submission Date that Met QC Criteria

Mar 15, 2012

First Posted Date

Mar 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2012

Last Update Posted Date

Apr 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group TACE	Active Comparator	Patients who undergo TACE	Procedure: Transarterial Chemoembolization (TACE)
Group Combination	Experimental	Patients who are treated with sorafenib combined with TACE	Other: Sorafenib in combination with TACE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transarterial Chemoembolization (TACE)	Procedure	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 .

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE)	Measure:time-to-proression	1 year

Secondary Outcomes

Measure	Description	Time Frame
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
Survival in the two treatment groups

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009369	Neoplasms
D004066	Digestive System Diseases

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009536	Niacinamide
D009539	Nicotinic Acids
D000147	Acids, Heterocyclic
D006571	Heterocyclic Compounds
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring

ID	Term
D008113	Liver Neoplasms
D006528	Carcinoma, Hepatocellular
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D008107	Liver Diseases
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type