140P - Tislelizumab combined with lenvatinib and transarterial chemoembolization(TACE) neoadjuvant treatment in resectable CNLC IIa-IIb hepatocellular carcinoma: A prospective, single-arm, phase II study

Background

The high recurrence rate after surgical resection remains a big challenge for long-term survival of HCC patients. In order to improve the R0 resection rate, reduce distant metastasis, and lower postoperative recurrence, there is a growing exploration of perioperative treatment. This study aimed to evaluate the efficacy and safety of combining tislelizumab with Lenvatinib and TACE as neoadjuvant therapy in resectable CNLC IIa-IIb HCC patients.

Methods

This study (ClinicalTrials.gov NCT06003673) enrolled patients with primary resectable HCC of CNLC IIa-IIb who had not received prior systemic therapy. For CNLC IIa patients must meet one of the following criteria: unclear tumor boundaries, proximity to blood vessels, or suspicious residual margins. TACE will be performed once only on Day 1. Tislelizumab (200 mg, IV, Q3W) and lenvatinib (bodyweight ≥ 60 kg, 12 mg; < 60 kg, 8 mg) orally daily was initiated on Day1. All patients undergo 2 cycles of neoadjuvant therapy. Patients will undergo surgical resection within 2-4 weeks after neoadjuvant treatment depends on the investigators’ evaluation. Primary endpoint was relapse-free survival (RFS). Secondary endpoints were objective response rate (ORR) by RECIST v1.1, Pathological Complete Response Rate (pCR), Major pathological reactions (MPR), R0 resection rates, overall survival (OS), and adverse events (AE).

Results

Between July 2023 and August 2024, 23 patients were enrolled. As of September 29, 2024, after a median follow-up of 9.4 months. All patients received neoadjuvant, and 19 patients underwent successful R0 resection, 7 patients (7/19,36.9%) achieved complete pathological response, 10 patients (10/19, 52.6%) achieved major pathological reaction (necrosis > 90%). The median age was 59 years old,all Child-Pugh A(100%), ECOG PS 0(100%), mostly males (82.6%), HBV infection (76.2%), BCLC B(100%) and CNLC IIa (63.6%). No grade 4 or 5 TRAE were observed. Median RFS and overall survival were not reached.

Conclusions

Lenvatinib, tislelizumab, and TACE were safe and showed promising efficacy as a neoadjuvant therapy for resectable HCC of CNLC IIa-IIb . Further follow up will continue.

Clinical trial identification

NCT06003673.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.