Study of Lenvatinib, Tislelizumab, and TACE as Pre-Surgery Treatment for Liver Cancer Patients with High Recurrence Risk CNLC Stage IB and IIA

What this Trial Is About

Researchers are evaluating the combination of Lenvatinib, Tislelizumab, and TACE as a preoperative treatment for patients with stage IB and IIA hepatocellular carcinoma HCC who have a high risk of cancer recurrence. This phase 2, single-arm, open-label study focuses on improving outcomes for patients with narrow or no surgical margins and high tumor marker levels. The study aims to assess the major pathological response along with other important measures such as complete response, surgical success, tumor control, and treatment side effects. The treatment includes TACE cycles with pharmorubicin and oxaliplatin every 4 to 5 weeks, Tislelizumab given every 3 weeks at 200mg, and daily Lenvatinib dosed based on body weight 8mg for under 60kg, 12mg for 60kg or above. Patients receive these treatments before surgery as part of the neoadjuvant regimen. The study period for evaluating responses and safety is approximately 16 weeks, including up to four treatment cycles. Participants will undergo evaluations such as pathological assessments of tumor response, imaging to measure tumor control, and monitoring for any treatment-related adverse events during the treatment period. Liver function and organ health will be closely followed, along with survival outcomes related to recurrence-free survival. The total participation time covers the treatment cycles and follow-up assessments up to 16 weeks after starting the regimen.

Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High-risk Recurrence Factors