138P - Interim results of neoadjuvant TACE plus lenvatinib and tislelizumab in resectable HCC at CNLC stages IB and IIA with high-risk of recurrence: A prospective, single-arm, phase II trial

Background

Until recently, neoadjuvant therapy for HCC has been limited by a lack of effective approaches. Prior studies have shown that patients (pts) achieving major pathological response (MPR) with neoadjuvant therapy have improved recurrence-free survival (RFS) in early-stage hepatocellular carcinoma (HCC). This prospective study aimed to explore the efficacy and safety of TACE combined with lenvatinib and tislelizumab in high-risk resectable HCC pts.

Methods

Eligible pts aged ≥18 years with histologically confirmed HCC at CNLC stage IB and IIA, Child-Pugh A and ECOG PS 0. High recurrence risk defined as narrow (margin <1cm) or absent surgical margins. Pts received neoadjuvant TACE (Q4W), lenvatinib (8 or 12 mg once daily for body weight <60 or ≥60 kg) and tislelizumab (200 mg IV Q3W), up to 4 cycles. Assessments were conducted every two cycles. The primary endpoint was MPR rate (necrosis ≥ 70%). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), R0 resection rate, and treatment-related adverse effects (TRAEs).

Results

By 10th Sep 2024, 18 pts were enrolled. 15 pts completed neoadjuvant therapy and each conducted two cycles, while 3 were still in treatment. The ORR and DCR were both 93.3% with 8 complete response (CR) pts per mRECIST. 12 pts underwent surgery, and all achieved negative surgical margin. 3 pts did not undergo surgery: 1 occurred disease progression, 1 due to inadequate liver function, 1 was being treated for coronary heart disease which resulted in surgery delay. The primary endpoint, MPR rate reached 92.3% with an average tumor necrosis rate of 89.9%. Notably, 2 pts had complete tumor necrosis. No grade 3 or above TRAEs were observed. As of 20^th Sep, no patients have experienced recurrence.

Conclusions

Neoadjuvant TACE Plus Lenvatinib and Tislelizumab showed a favorable pathological response rate and safety profile. The study is ongoing, long term survival benefits needs further evaluated and data will be updated in future.

Clinical trial identification

NCT05920863.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.