Adjuvant Chemotherapy With FOLFOX in HCC Patients After Resection
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second
leading cause of cancer-related death. Surgical resection is still the main radical approach
for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further
improvement of prognosis of HCC patients. The conventional risk factors of recurrence
including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the
microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after
hepatectomy. The investigators' previous study showed that the recurrence rate is more than
50% for the patients with >5cm solitary tumor and MVI. The MVI was confirmed as the only
independent risk factor for the overall and disease-free survival of HCC patients in multiple
variables analysis. It is important to reduce the recurrence and prolong the survival of
patients after hepatectomy with effective adjuvant therapy. Reported at 2014 American Society
of Clinical Oncology (ASCO) annual meeting, A phase III randomized, double-blind,
placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent
recurrence of hepatocellular carcinoma (STORM trial) failed to meet the primary
endpoint-recurrence free survival (RFS). Given the inspiring result of a recent trial, which
compared with single agent of doxorubicin, the oxaliplatin-containing regimens (FOLFOX)
showed significant improvement in OS, objective response rate (ORR) and disease control rate
(DCR) in Asian (especially China) HCC patients. Based on these rationales, the investigators
design the current prospective randomized clinical trial to evaluate the effect of adjuvant
chemotherapy with FOLFOX to prolong the overall survival and reduce the recurrence in HCC
patients at high risk (>5cm solitary tumor and MVI) after resection, compared to vigilant
follow-up.