There are limited treatment options for patients with unresectable hepatocellular carcinoma (HCC) who failed to the combination therapy with targeted agents plus anti-PD-1/PD-L1. Hepatic artery infusion chemotherapy (HAIC) had shown potent antitumor effects in single-centered studies when was used as first-line therapy. However, HAIC was not used as second or third-line therapy.
The combination therapy of anti-angiogenic agents and anti-PD-1/PD-L1 antibodies had shown potent anti-tumor efficacy for unresectable or advanced hepatocellular carcinoma. However, the treatment options were limited when patients were failed the combination therapies. Hepatic artery infusion chemotherapy (HAIC) had shown potent anti-tumor efficacy with an acceptable safety profile as a first-line treatment for patients with intermediated-stage or advanced-stage hepatocellular carcinoma. In this study, the investigators aimed to evaluate the efficacy and safety of HAIC were used in the late-line setting, i.e., after the failure of combination therapy with anti-angiogenic agents and anti-PD-1/PD-L1 antibodies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
The FOLFOX regiments were given via hepatic artery catheterization, including oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, fluorouracil bolus 400 mg/m2, followed by fluorouracil infusion 2400 mg/m2 for 46 hours. If no severe adverse events occurred, the treatment will be repeated every 3 weeks.
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response of intrahepatic lesions
Subjects with complete response or partial response assessed by RECIST v1.1 criteria.
Time frame: up to 1 year
duration of response of intrahepatic lesions
the interval between the time of partial or complete response to the time of progressive disease in intrahepatic lesions.
Time frame: up to 1 year
Progression free survival
the interval between the time of first HAIC treatment to the time of progressive disease or patient death
Time frame: up to 1 year
Overall survival
the interval between the time of first HAIC treatment initiation to the time of patient death
Time frame: up to 2 year
Treatment cycles of HAIC
the total cycles of HAIC treatments, when the subjects could not tolerate HAIC or lose the benefit from HAIC treatment, HAIC will be discontinued.
Time frame: up to 1 year
Ratio of R0 resection
The ratio of subjects who underwent R0 resection to subjects received who received at least 1 cycle of HAIC.
Time frame: up to 1 year
The rate of adverse events
Nature, incidence, severity and seriousness of the adverse events. Adverse events are graded according to the NCI-CTCAE (Version 5.0)
Time frame: up to 1 year
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