Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic liver cancer A-B stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
304
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC
Patients receive normal saline 10ml in each session of HAIC
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGOverall survival (OS)
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Time frame: 24 months
Progression free survival (PFS)
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Time frame: 24 months
Number of adverse events
Postoperative adverse events were graded based on CTCAE v4.03
Time frame: 30 days
Conversion rate to resection
Patients receive subsequent resection.
Time frame: 24 months
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