Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. During the disease course, 20%-50% patients suffered portal vein tumor thrombus (PVTT), which is characterized with poor outcome and low response for treatments. Although BCLC (Barcelona clinical liver cancer) system recommend to palliative targeted treatment, the East Asian countries recommend to resection or transartery chemoembolization (TACE). Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for patients with PVTT is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h+5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
hepatic resection remove the liver tumor and portal vein tumor thrombus
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival, PFS
PFS was calculated from the date of starting treatment to the date of progression, of disease or death.
Time frame: 36 months
Overall survival, OS
OS was calculated from the date of starting treatment to the date of death.
Time frame: 60 months
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