Carcinoma, Hepatocellular
Conditions
Keywords
HCC, PVTT, Folofox4, Early Recurrence
Brief summary
This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for hepatocellular carcinoma patients with portal vein tumor thrombus following curative resection
Detailed description
Curative resective is well-accepted as the predominant treatment for hepatocellular carcinoma (HCC) patients. Unfortunately, the long-term prognosis remains poor due to frequent postoperative recurrence, especially in HCC patients with portal vein tumor thrombus (PVTT). When PVTT invades into the portal vein system, tumor cell spreads and distributes along with the portal vein and its branches,thus resulting in intra-hepatic micro-metastasis which contributes to early recurrence for patients following curative resection. Postoperative adjuvant interventions include TACE, antiviral therapy, immunotherapy, local radiotherapy were applied to prevent recurrence. However, the efficacy and safety of these regimens remains unsatisfactory. Thus new therapeutic strategy remains to be investigated. This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for HCC patients with PVTT following curative resection.
Interventions
DRUGfolfox4 chemotherapy regimen
Folfox regimen:Oxaliplatin 85 mg/m2 in 250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1;leucovorin 200 mg/m2 in 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 400 mg/m2 5-FU in 20mL 0.9% NaCl solution, IV(administered as follow leucovorin); then 600 mg/m2 5-FU in 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle. Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops.
OTHERPlacebo
Placebo regimen:250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1; 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 20mL 0.9% NaCl solution, IV; then 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle. Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops.
Sponsors
Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients undergo curative resection * HCC with PVTT is confirmed by pathological examination * patients undergo chemotherapy of Folfox4 regimen * patients without recurrence within the first month after curative resection * residual hepatic function is Child-pugh A or B which is capable to tolerate chemotherapy * patients without other postoperative adjuvant treatments including TACE, radiotherapy, immunotherapy
Exclusion criteria
* Multipal intra-hepatic or outra-hepatic tastasis within the first month after curative resection * patients with residual hepatic function Child-pugh C is not capable to tolerate chemotherapy * patients undergo postoperative adjuvant treatments except chemotherapy of Folfox4 regimen * patients with badly chemotherapy complications who can finish the whole Folfox4 treatment course
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| early recurrence | from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | from date of randomization until the date of death from any cause, whichever came first, assessed up to 5 years |
Contacts
Primary ContactJiazhou Ye, M.D.
Backup ContactLequn Li, M.D.
Outcome results
None listed