Lenvatinib Plus TACE Versus Sorafenib Plus TACE for HCC With PVTT
Status:
Enrolling by invitation
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Hepatocellular carcinoma (HCC) is the fourth most common cancer in China, with a crude
incidence rate of 26.67 per 100,000 population. Moreover, 357,800 new liver cancer cases are
predicted to be diagnosed in China in 2020. HCC represents approximately 90% of all cases of
primary liver cancer. HCC has a high predilection for portal vein invasion, which occurs in
44-62% of living patients with HCC. Patients with PVTT usually have an aggressive disease
course, decreased liver function reserve, limited treatment options, thus worse overall
survival. Among untreated HCC patients with PVTT, the median overall survival has been
reported as low as 2 to 4 months with supportive care. Sorafenib is the first-line treatment
for HCC patients with PVTT, however, it has shown unsatisfactory benefit. Notably, sorafenib
combined with TACE significantly improved the TTP over sorafenib alone, albeit for no more
than 1 month in the median TTP, and the median OS was not significantly prolonged. A
promising drug-lenvatinib was approved in China on September 2018, in the China patients
subgroup analysis showed an encouraging results. Lenvatinib group had showed a significant
benefit in TTP, PFS and ORR. Also median overall survival time was significantly improved in
China subgroup (Lenvatinib group: 15 months VS Sorafenib group: 10.2 months). However,
REFLECT didn't enrolled patients who had tumors invading the maint portal vein. The
mechanisms of lenvatinib or sorafenib combined with TACE were still unknown, and clinical
data were limited.
This study was to explore lenvatinib plus TACE versus sorafenib plus TACE for HCC with PVTT:
efficacy and safety. Biomarkers expression of VEGFR, FGFR, FDGF-α, IL-2,etc would be detected
to find the difference between the two groups, finally to analyze the relationship between
clinical outcomes and biomarkers' expression. A better treatment modality to HCC with PVTT
patients would be expected and promoted.