The purpose of this study is to evaluate the efficacy and safety of resection plus neoadjuvant hepatic arterial infusion chemotherapy (HAIC) compared with resection alone in patients with resectable hepatocellular carcinoma beyond Milan criteria.
Resection is the long-term therapeutic option for resectable hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect and high relapse rate of resection for patients with resectable hepatocellular carcinoma beyond Milan criteria. Our previous prospective study also revealed that neoadjuvant transarterial chemoembolization (TACE) seems to confer a survival benefit for resectable HCC. Recently, the results of our previous prospective study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large HCC.Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of resection plus neoadjuvant HAIC over resection alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
252
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
R0 resection
Dongguan People's Hospital
Dongguan, Guangdong, China
RECRUITINGCancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Overall survival
Time to death
Time frame: 60 months
Disease-free survival
Time to recurrence or death
Time frame: 60 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.0
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Guangzhou Twelfth People's Hospital
Guangzhou, Guangdong, China
RECRUITINGKaiping Central Hospital
Kaiping, Guangdong, China
RECRUITINGThe First Affiliated Hospital of University Of South China
Hengyang, Hunan, China
RECRUITINGFirst Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, China
RECRUITING