TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

NCT ID: NCT01605734

Last Updated: 2012-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group TACE

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

Group Type: ACTIVE_COMPARATOR

TACE

Intervention Type: PROCEDURE

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.

Group Combination

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

Group Type: EXPERIMENTAL

sorafenib combined with TACE

Intervention Type: DRUG

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

Interventions

TACE

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: PROCEDURE

sorafenib combined with TACE

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: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Jinlong Song

Chief, Division of Interventiolal Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinlong Song, MD

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Locations

Shandong Medical Imaging Research Institute

Jinan, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

the Affiliated Hospital of Medical College Qingdao University

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Countries

China

Central Contacts

Jinlong Song, MD

Role: CONTACT

songjlmd@gmail.com

+8653167626411

Wenbo Shao, MD,Ph D

Role: CONTACT

shaowenbomd@gmai.com

+8653167626412

Facility Contacts

Jun Tang, MD

Role: primary

tangjun7925032@163.com

+8613964031909

Caixia Li, MD

Role: primary

Lilyshanda88@hotmail.com

+8613505312972

Zixiang Li, MD

Role: primary

zixiangli@yahoo.com.cn

+8618669739263

Yanbo Zheng, MD

Role: primary

13805356068@163.com

+8613805356068

Other Identifiers

ShandongCHI-002

Identifier Type: -

Identifier Source: org_study_id