This is a single center, non-randomized, open, multi-cohort clinical, exploratory Phase II study, to evaluate the efficacy and safety of HAIC combined with TQB2450 and anlotinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients at high risk of recurrence after resection.
The high incidence of HCC recurrence following liver resection is a serious issue. However, no adjuvant therapy has been widely recognized at present. Interventional therapy and systemic drug therapy are common treatment methods and effective treatment for liver cancer. The combination of multiple drugs may reduce the recurrence in HCC patients with high-risk recurrence. TQB2450 is a humanized monoclonal antibody of programmed death-ligand1 (PD-L1), enabling T cells to restore immune activity and thus enhance the immune response. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) for tumor angiogenesis and proliferative signaling.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
HAIC: FOLFOX for 24hour perfusion chemotherapy. Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. TQB2450: 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGDisease Free Survival (DFS)
DFS defined as the time from date of randomization until the date of recurrence or death due to any cause
Time frame: 24 months
Overall survival (OS)
OS defined as the time from date of randomization until the date of death due to any cause
Time frame: 24 months
Time to recurrence (TTR)
TTR defined as the time from date of randomization until the date of recurrence.
Time frame: 24 months
Safety: adverse events
adverse events (AEs) categorized by severity in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Time frame: 24 months
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