Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Sorafenib
Brief summary
The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).
Detailed description
The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to find out it.
Interventions
DRUGSorafenib
administration of Sorafenib
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
DRUGFolfox Protocol
Oxaliplatin , fluorouracil, and leucovorin
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
The First Affiliated Hospital of University of South China
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 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. * portal vein tumor thrumbus confirmed in two image techniques * Eastern Cooperative Oncology Group performance status of 0 to 2 * 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
* 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. * Known central nervous system tumors including metastatic brain disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 6 months | Overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | 6 months | Time to progression |
| 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