Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Sorafenib, Oxaliplatin plus Fluorouracil/Leucovorin, Oxaliplatin
Brief summary
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).
Detailed description
Sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients with portal venous tumor thrombus (PVTT). Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to HCC with major PVTT. However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.
Interventions
DRUGSorafenib
Oral Sorafenib, 400mg, Bid
DRUGHAIC of FOLFOX
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
DRUGHAIC of OXA
administration of Oxaliplatin via the tumor feeding arteries
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Dongguan People's Hospital
Kaiping Central Hospital
First Affiliated Hospital Xi'an Jiaotong University
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
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
In the OXA group, saline replace the fluorouracil and leucovorin solution and patients are treated the same time as the FOLFOX group.
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. * diagnosed with major or main portal vein invasion (Vp3 or Vp4) * KPS≥70； * 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. * 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 | 10 months | Overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress free survival | 10 months | Progress free survival |
| Adverse Events | 30 days | Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.0 |
| 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 v4.0 |
| Tumor response | 10 months | overall response |
Countries
China
Contacts
Primary ContactMing Shi, MD
Backup ContactRongPing Guo, MD
Outcome results
None listed