Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma (TACEforHCC)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Full 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
Enrollment
Sex
Ages
Volunteers
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
- Total bilirubin ≤ 1.5 mg/dL
- ASL and AST ≤ 5 x upper limit of normal
- Serum albumin ≥ 35 g/L
- Serum creatinine ≤ 1.5 x upper limit of normal
- INR ≤ 1.5 or a Pt/PTT within normal limits
- Absolute neutrophil count (ANC) > 1,500/mm3
-
Ability to understand the protocol and to agree to and sign a written informed consent document
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
365 participants in 3 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal