966P - Borderline resectable hepatocellular carcinoma: Definitions, efficacy and safety results from a prospective phase Ib/II study evaluating camrelizumab plus lenvatinib combined with TACE as preoperative therapy (BRHCC)

Background

In selecting patients with initially resectable hepatocellular carcinoma (HCC), preoperative treatment may play a crucial role in reducing the risk of early post-surgery recurrence. This study defined 'Borderline-resectable' HCC and investigated the efficacy and safety of Camrelizumab plus Lenvatinib with TACE as preoperative therapy. BRHCC signifies a window enabling tumor resection, selecting patients with stable or responsive disease for surgery after neoadjuvant therapy, with the aim of optimizing oncological outcomes.

Methods

This prospective phase Ib/II trial (NCT05042336) enrolled patients with BRHCC, defined as: (1) Single tumor > 10 cm; (2) 2-3 tumors, any > 3 cm; (3) ≥4 nodules, not exceeding half the liver; (4) Portal vein tumor thrombus grade ≤ Cheng's classification I/II (VP2-3); and (5) no extrahepatic metastasis. Patients received TACE combined with Lenvatinib and Camrelizumab (200 mg iv q3w or q2w in Phase Ib, and q2w in Phase II). Primary endpoints: primary pathological response rate (MPR) and adverse events (safety assessed via CTCAE 5.0). Secondary endpoints: pathological complete response rate (pCR), objective response rate (ORR, assessed via mRECIST), disease control rate (DCR), disease-free survival (DFS), and overall survival (OS).

Results

The Data cutoff date was April 30^th, 2024. A total of 54 patients included and 50 reached primary endpoints. For the 6 pts in Phase Ib, no severe AEs were recorded, and another 48 pts were enrolled in phase II trial. Among the 54 included pts in this Ib/II trial, 44 received surgical resection. Median DFS or OS did not reached. Table: 966P

BRHCC study information

Conclusions

The preoperative combination therapy of Camrelizumab and Lenvatinib with TACE showed tolerable safety and notable anti-tumor activity in borderline resectable HCC patients. Comprehensive safety, pathological, and clinical response data will be provided.

Clinical trial identification

NCT05042336.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

The National multidisciplinary collaborative diagnosis and treatment capacity building project for major diseases (TJZ202104), the Natural Science Foundation of China (82173248, 82272685, 82002967 and 82202260), the Postdoctoral Science the fellowship of China National Postdoctoral Program for Innative Talents (BX20200225), the Project funded by China Postdoctoral Science Foundation (2022TQ0221), the Science and Technology Major Program of Sichuan Province (2022ZDZX0019), the Sichuan Science and Technology Program (2023YFS0128, 2023NSFSC1874, 2021YJ0420), 1.3.5 project for disciplines of excellence, West China Hospital, Sichuan University (ZYJC18008, ZYGD22006).

Disclosure

All authors have declared no conflicts of interest.