Hepatocellular Carcinoma
Conditions
Keywords
Antineoplastic Agents, administration & dosage, Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Humans, Liver Neoplasms, therapy
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
Interventions
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
Sponsors
Ministry of Health, China
Guangdong Provincial People's Hospital
The 458 Hospital of Chinese PLA
Kaiping Central Hospital
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | 3 years |
Countries
China
Outcome results
None listed