TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01605734
• Other study ID #: ShandongCHI-002
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 11, 2012
• Last updated: May 21, 2012
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2012
• Source: Shandong Cancer Hospital and Institute
• Contact: Jinlong Song, MD
• Phone: +8653167626411
• Email: songjlmd[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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.

Drug:
• 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

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Cancer Hospital and Institute	Jinan	Shandong
China	Shandong Medical Imaging Research Institute	Jinan	Shandong
China	the Affiliated Hospital of Medical College Qingdao University	Qingdao	Shandong
China	Yantai Yuhuangding Hospital	Yantai	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression	Time to progression is defined as time from randomization to radiological progression and will be evaluated every 8 week	1 year	No
Secondary	FACT-Hep	FACT-Hep is a chart established to evaluate the life quality of patients with HCC every 4 weeks	six months	No
Secondary	Disease control rate	CR+PR+SD	six months after TACE	No
Secondary	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)	six months	Yes
Secondary	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	two years	No
Secondary	Number of TACE sessions and the interval time between two TACE sessions		2 years	No
Secondary	AFP		six months	No