Chemoembolization of Unresectable Hepatocellular Carcinoma With or Without Mixing the Chemotherapy With Lipiodol: Effectiveness and Safety. A Prospective and Randomized Clinical Trial.

Sun Yat-sen University1 site in 1 country668 target enrollmentAugust 2013

ConditionsHepatocellular Carcinoma

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 668
Locations: 1
Primary Endpoint: overall survival
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

TACE is considered the standard treatment for unresectable HCC on the basis of the fact that there are no alternative to curative procedures.But the optimal combined regimen is still unclear. One of the controversy is do the protocol should contain lipiodo and how to executer. The investigators hypothesize that TACE without mixing the chemotherapy with lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

August 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Shi Ming

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Adults patients with a diagnosis of HCC which is not amenable to surgical resection ,local ablative therapy and any other cured treatment.
•Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. And the lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
•No serious concurrent medical illness
•Unresectable BCLC stage A-B disease
•No cirrhosis or cirrhotic status of Child-Pugh class A
•No significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis
•No current infections requiring antibiotic therapy
•Not on anticoagulation or suffering from a known bleeding disorder
•No unstable coronary artery disease or recent MI
•The following laboratory parameters:

Exclusion Criteria

•Known history of HIV
•History of organ allograft
•Pregnant or breast-feeding patients
•Known or suspected allergy to the investigational agents or any agent given in association with this trial.
•Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
•Evidence of bleeding diathesis.
•Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
•Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
•Serious non-healing wound, ulcer, or bone fracture
•Known central nervous system tumors including metastatic brain disease