Hepatocellular Carcinoma
Conditions
Keywords
Hepatic arterial infusion chemotherapy, Transarterial Chemoembolization
Brief summary
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with BCLC stage hepatocellular carcinoma (HCC).
Detailed description
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. Our previous prospective study also revealed that TACE confers a survival benefit to patients with HCC and portal venous tumor thrombus (PVTT). Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for patitens with BCLC stage C HCC. Thus, the investigators carried out this prospective randomized control study to find out it.
Interventions
PROCEDURETransarterial chemoembolization
DRUGTACE regimen
infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)
DRUGHAIC Regimen
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
DRUGOral Sorafenib
Oral Sorafenib, 400mg, Bid
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis of BCLC C stage HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) * Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. * with no previous treatment * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not amendable to surgical resection ,local ablative therapy and any other cured treatment. * The following laboratory parameters: * Platelet count ≥ 75,000/µL * Hemoglobin ≥ 8.5 g/dL * Total bilirubin ≤ 30mmol/L * Serum albumin ≥ 30 g/L * ASL and AST ≤ 5 x upper limit of normal * Serum creatinine ≤ 1.5 x upper limit of normal * INR ≤ 1.5 or PT/APTT 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
* Main portal vein occlusion * Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 18 months | Overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress free survival | 18 months | Progress free survival |
| Adverse Events | 30 Days | Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0 |
| Number of of Patients developed Adverse Events | 30 Days | Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0 |
Countries
China
Outcome results
None listed