This is a prospective, multicenter, randomized controlled, phase 3 study to explore the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.
Voluntarily participates in this study and provides written informed consent.
Aged 18 to 75 years, inclusive; male or female.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
Child-Pugh class A liver function.
Prior antitumor therapy for the current HCC, including radiotherapy, chemotherapy, concurrent chemoradiotherapy, other locoregional therapies (e.g., TACE, HAIC), or prior immunotherapy or targeted therapy.
Known cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular-cholangiocarcinoma, or fibrolamellar carcinoma; or any other active malignancy besides HCC within the past 5 years or concurrently (except cured basal cell carcinoma of the skin and cervical carcinoma in situ).
Hypertension inadequately controlled with antihypertensive therapy (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg); or history of hypertensive crisis or hypertensive encephalopathy.
Known hypersensitivity to macromolecular protein preparations, or known allergy to tislelizumab, lenvatinib, or any of their excipients.
Parallel
Tislelizumab
DrugTislelizumab, 200mg, IV, q3w. Treatment will be given in 3-week cycles for a total of 2 cycles.
Lenvatinib
DrugLenvatinib, 8mg for BW\<60kg or 12mg for BW≥60kg, PO, qd. Treatment will be given in 3-week cycles for a total of 2 cycles.
1-year event-free survival rate
Objective response rate
Disease control rate
Major pathologic response rate
1-year recurrence-free survival rate
Response prediction accuracy (AUC-ROC)
Exploratory endpoint: Area under the receiver operating characteristic curve for AI-predicted response probability
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