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TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

TACE

sorafenib combined with TACE

About this trial

This is an interventional treatment trial for PHENYTOIN/SORAFENIB [VA Drug Interaction] focused on measuring hepatocellular carcinoma, transarterial chemoembolization, sorafenib

Eligibility Criteria

18 Years - 75 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 or C
Child-Pugh class score≤8
ECOG performance status ≤2
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 18-75 years
Haematology:Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 50 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)< 5 x the upper limit of normal,Total bilirubin < 3 x the upper limit of normal,Serum creatinine < 1.5 x the upper limit of normal,Cholinesterase>0.5x the lower limit of normal，Prealbumin>0.5x the lower limit of normal.
Life expectancy of > 3 months

Exclusion Criteria:

BCLC stage D
Child-Pugh Score≥9
Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
Preexisting or history of hepatic encephalopathy
uncontrolled hypertension
Pregnancy (positive serum pregnancy test) or lactation
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
Other severe concomitant disease that may reduce life expectancy
Risk of allergic reactions to the study drugs
Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results

Sites / Locations

Shandong Medical Imaging Research Institute
Qilu Hospital of Shandong University
Shandong Cancer Hospital and Institute
the Affiliated Hospital of Medical College Qingdao University
Yantai Yuhuangding Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group TACE

Group Combination

Arm Description

TACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated if clinically indicated

All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study

Outcomes

Primary Outcome Measures

Time to Progression

Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week

Secondary Outcome Measures

FACT-Hep

FACT-Hep is a chart established to evaluate the life quality of patients with HCC every 4 weeks

Disease control rate

CR+PR+SD

Safety

Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)

PFS and OS

The overall survival is defined as time from randomization to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period,respectively

Number of TACE sessions and the interval time between two TACE sessions

AFP

Full Information

NCT ID

NCT01605734

First Posted

May 11, 2012

Last Updated

May 21, 2012

Sponsor

Shandong Cancer Hospital and Institute

1. Study Identification

Unique Protocol Identification Number

NCT01605734

Brief Title

TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

Official Title

Phase II Trail of TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 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

Yes

5. Study Description

Brief Summary

TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

hepatocellular carcinoma, transarterial chemoembolization, sorafenib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group TACE

Arm Type

Active Comparator

Arm Description

TACE will be carried out with chemotherapeutic agents and lipiodol; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated if clinically indicated

Arm Title

Group Combination

Arm Type

Experimental

Arm Description

All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study

Intervention Type

Procedure

Intervention Name(s)

TACE

Intervention Description

After obtaining arterial access,a diagnostic visceral arteriogram will be performed to demonstrate arterial supply to the tumor and the presence of variant arterial anatomy.After having positioned the catheter within the artery feeding tumor,the chemoembolization mixture will be infused into th e artery until stagnant flow is observed.

Intervention Type

Drug

Intervention Name(s)

sorafenib combined with TACE

Intervention Description

All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study

Primary Outcome Measure Information:

Title

Time to Progression

Description

Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week

Time Frame

1 year

Secondary Outcome Measure Information:

Title

FACT-Hep

Description

FACT-Hep is a chart established to evaluate the life quality of patients with HCC every 4 weeks

Time Frame

six months

Title

Disease control rate

Description

CR+PR+SD

Time Frame

six months after TACE

Title

Safety

Description

Number of participants with adverse events as a measure of safety and tolerability(According to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)

Time Frame

six months

Title

PFS and OS

Description

Time Frame

two years

Title

Number of TACE sessions and the interval time between two TACE sessions

Time Frame

2 years

Title

AFP

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria. BCLC stage B or C Child-Pugh class score≤8 ECOG performance status ≤2 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 18-75 years Haematology:Absolute neutrophil count (ANC) > 1.5 x 109/L, Platelet count > 50 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5 Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)< 5 x the upper limit of normal,Total bilirubin < 3 x the upper limit of normal,Serum creatinine < 1.5 x the upper limit of normal,Cholinesterase>0.5x the lower limit of normal，Prealbumin>0.5x the lower limit of normal. Life expectancy of > 3 months Exclusion Criteria: BCLC stage D Child-Pugh Score≥9 Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment Preexisting or history of hepatic encephalopathy uncontrolled hypertension Pregnancy (positive serum pregnancy test) or lactation 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 Other severe concomitant disease that may reduce life expectancy Risk of allergic reactions to the study drugs Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jinlong Song, MD

Phone

+8653167626411

songjlmd@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Wenbo Shao, MD,Ph D

Phone

+8653167626412

shaowenbomd@gmai.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 Medical Imaging Research Institute

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250021

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Tang, MD

Phone

+8613964031909

tangjun7925032@163.com

First Name & Middle Initial & Last Name & Degree

Jun Tang, MD

Facility Name

Qilu Hospital of Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250114

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caixia Li, MD

Phone

+8613505312972

Lilyshanda88@hotmail.com

First Name & Middle Initial & Last Name & Degree

Caixia Li, MD

Facility Name

Shandong Cancer Hospital and Institute

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250117

Country

China

Facility Name

the Affiliated Hospital of Medical College Qingdao University

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266003

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zixiang Li, MD

Phone

+8618669739263

zixiangli@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Zixiang Li, MD

Facility Name

Yantai Yuhuangding Hospital

City

Yantai

State/Province

Shandong

ZIP/Postal Code

264000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanbo Zheng, MD

Phone

+8613805356068

13805356068@163.com

First Name & Middle Initial & Last Name & Degree

Yanbo Zheng

12. IPD Sharing Statement

Learn more about this trial

TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

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