TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

NCT01605734 | Unknown Phase 2 DMC

• 1 other identifier: ShandongCHI-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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

Keywords

hepatocellular carcinoma; transarterial chemoembolization; sorafenib

Outcome Measures

Primary Outcomes (1)

• Time to Progression

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

  1 year

Secondary Outcomes (6)

• FACT-Hep

  six months

• Disease control rate

  six months after TACE

• Safety

  six months

• PFS and OS

  two years

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

  2 years

Study Arms (2)

Group TACE

ACTIVE COMPARATOR

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

Procedure: TACE

Group Combination

EXPERIMENTAL

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

Drug: sorafenib combined with TACE

Interventions

TACE 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 TACE

sorafenib combined with TACE 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

Group Combination

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (5)

Shandong Medical Imaging Research Institute

Jinan, Shandong, 250021, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250114, China

Location

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

Location

the Affiliated Hospital of Medical College Qingdao University

Qingdao, Shandong, 266003, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jinlong Song, MD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinlong Song, MD

CONTACT

+8653167626411; songjlmd@gmail.com

Wenbo Shao, MD,Ph D

CONTACT

+8653167626412; shaowenbomd@gmai.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Interventiolal Therapy

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 25, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: May 25, 2012

Record last verified: 2012-05

Locations

CN (5)