RFA Combined With Oxaliplatin + 5-FluoroUracil/LeucoVorin (5-FU/LV) (FOLFOX4) for Recurrent HCC
Status:
Unknown status
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
Summary
Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial
hepatectomy and liver transplantation are considered to be standard curative therapies for
HCC. When surgery is not possible, percutaneous ablation is usually considered to be
alternative treatments for HCC. Recurrence is the most frequent serious adverse event
observed during the follow-up of HCC patients treated for cure. Repeat hepatectomy is an
effective treatment for HCC recurrence, with a 5-year survival rate of 19.4 to 56%.
Unfortunately, repeat hepatectomy can be performed only in a small proportion of patients
with HCC recurrence (10.4 to 31%), either because of the poor functional liver reserve or
because of widespread recurrence. Radiofrequency ablation has been considered to be one of
the most effective percutaneous ablations for early-stage HCC in patients with or without
surgical prospects. Studies using RFA to treat HCC recurrence after hepatectomy have reported
a 3-year survival rate of 62% to 68%, which is comparable to those achieved by surgery. RFA
is particularly suitable to treat HCC recurrence after hepatectomy because these tumors are
usually detected when they are small, and because RFA causes the least deterioration of liver
function in the patients. However, according to our previous study, investigators found the
recurrent rate after RFA was higher than 60%. Systemic chemotherapy is considered to be one
of the main treatments for malignant tumors. HCC is known to be highly refractory to
conventional systemic chemotherapy because of its heterogeneity and multiple etiologies.
Before the advent of the molecular-targeted agent sorafenib, which has subsequently become
the standard of care, no standard systemic drug or treatment regimen had shown an obvious
survival benefit in HCC. Nowadays, there is no systemic chemotherapy regimen had been
definitively recommended as the standard for treating HCC. Clinical activity of several
regimens containing oxaliplatin (OXA) in advanced HCC had been demonstrated in phase II
studies. In a phase II study of the FOLFOX4 (infusional fluorouracil [FU], leucovorin[LV],
and OXA) regimen in Chinese patients with HCC, median overall survival (OS) was 12.4 months,
mean time to progression was 2.0 months, and the response rate (RR) was 18.2%. The safety
profile was acceptable. Recently, the results of a phase Ⅲ randomize study showed that
FOLFOX4 served as palliative chemotherapy can induce higher overall survival,
progression-free survival and response rate comparing to doxorubicin in patients with
advanced hepatocellular carcinoma from Asia. The safety data was also acceptable. Therefore,
investigators considered RFA to be an effective treatment for HCC recurrence after curative
treatment. So our hypothesis is that RFA combined with FOLFOX4 can reduce high recurrence
rate after RFA for recurrent HCC after hepatectomy. The aim of this open-lable, single
prospective study is to evaluate the efficacy and safety of RFA combined with FOLFOX4
systemic chemotherapy for recurrent HCC after partial hepatectomy.