Hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin\&5-fluorouracil was effective in unresectable hepatocellular carcinoma (HCC). The program of FOLFOX-HAIC in HCC was performed for 1 day (HAIC 1d) or 2 days (HAIC 2d). We hereby retrospectively compared the efficacy and safety between these two treatment regimens, and explored the predictive power of thymidylate synthase (TYMS), an enzyme involved in the DNA synthesis process and metabolism of fluorouracil. Patients with HCC staged BCLC A-B receive HAIC only, and patients with HCC staged BCLC C receive HAIC plus systemic treatment, such as sorafenib, A+T, lenvatinib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
The microcatheter was advanced into the hepatic artery, and patients were transferred to the inpatient ward for drug infusion via the hepatic artery
Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 46 hours
Oxaliplatin, leucovorin, bolus fluorouracil, and infusional fluorouracil 2400 mg/m² over 23 hours
The First People's Hospital of Foshan
Foshan, Guangdong, China
RECRUITINGCancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGGuangzhou Twelfth People 's Hospita
Guangzhou, Guangdong, China
RECRUITINGOverall survival
time from randomzation to death
Time frame: 24 months
Progression-free survival
time from randomzation to progression or death, which occur firstly.
Time frame: 12 months
objective response rate per RECIST 1.1
CR plus PR per RECIST 1.1
Time frame: 12 months
Adverse Events
Adverse Events according to CTCAE 4.0
Time frame: 30 days
the predictive power of thymidylate synthase (TYMS)
the correlation between thymidylate synthase (TYMS) and survival. Whether the survival of patients with low TYMS is better than those with high TYMS
Time frame: 12 months
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