The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 365
- Locations
- 1
- Primary Endpoint
- Overall survival
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).
Detailed Description
Transarterial chemoembolization (TACE) has been recommended as first line non-curative therapy for non-surgical patients with large/multifocal HCC who do not have vascular invasion or extrahepatic spread. There has not been any standardized protocol in the choice of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of embolization, and whether the chemotherapeutic agent should be given together, or before the embolizing agent. Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE. Regimen 1: lipiodol combined chemotherapy with embolization Regimen 2: lipiodol combined chemotherapy without embolization Regimen 3: lipiodol single agent chemotherapy with embolization
Investigators
Shi Ming
Dr.
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Adult patients with minimal height of 150cm and minimal weight of 50 KG
- •Histological confirmed HCC
- •with no previous treatment
- •With unresectable tumor
- •With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm.
- •No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
- •No significant renal impairment (creatinine clearance \< 30 mL/minute)
- •The following laboratory parameters:
- •Platelet count ≥ 60,000/µL
- •Hemoglobin ≥ 8.5 g/dL
Exclusion Criteria
- •Avascular tumor
- •Main portal vein obstruction without cavernous transformation
- •Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
- •Obstructive jaundice
- •Severe underlying cardiac or renal diseases
- •Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Pregnant or breast-feeding patients.
- •History of organ allograft
- •Active clinically serious infections
- •Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Outcomes
Primary Outcomes
Overall survival
Time Frame: 3 years
Secondary Outcomes
- Time to progression(3 years)