This is a monocenter, single-arm, open-label study to evaluate the efficacy and safety of Lenvatinib combined with Tislelizumab and TACE applied as neoadjuvant regimen for the patients of CNLC stage IB and IIA hepatocellular carcinoma with high risk of recurrence Primary outcome: Major pathological response (MPR) Secondary outcomes: pathological complete response (pCR), R0 resection rate, objective response rate (ORR), disease control rate (DCR), treatment-related adverse events (TRAE)
Aged 18-75 years old (inclusive);
HCC is confirmed by preoperative pathological examination or meet the criterion of diagnosis and treatment norms of primary HCC issued by health commission, PRC. No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC;
Patients with CNLC IB or IIA stage tumors before surgery and meeting the following conditions: radiological evaluation shows narrow or none surgical margins, and preoperative tumor markers AFP+PIVKA is greater than 1600.
ECOG score of 0 before the first administration of the study drug;
Pathologically diagnosed as non-hepatocellular carcinoma;
Previously received anti-tumor treatments such as chemotherapy, radiotherapy, radiofrequency ablation, intervention, targeted therapy, immunotherapy or surgical treatment for liver cancer (excluding previous non-tumor-related surgery or diagnostic biopsy);
CNLC stage is IA, IIB or worse.
Viral load limited to hepatitis B virus (HBV) DNA>2000 copies/ml, hepatitis C virus (HCV) RNA>1000;
Single group
TACE
Procedure/SurgeryTACE: pharmorubicin 30mg, oxaliplatin 50mg, cycle 4-5 week.
Tislelizumab, Lenvatinib
DrugTislelizumab: 200mg, cycle 3 week. Lenvatinib: weight \<60kg, 8mg/day; weight ≥60kg, 12mg/day.
Major pathological response
Proportion of residual tumor ingredient lesser than 30% in the postoperative pathological result.
Pathological complete response
None residual tumor ingredient detected in the postoperative pathological result.
R0 resection rate
The proportion of patients achieved a complete resection with negative margin.
Objective response rate (ORR)
he proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1
disease control rate (DCR)
The percentage of patients who have achieved either a complete response (CR), a partial response (PR), or stable disease (SD) after undergoing treatment for their cancer.
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