Abstract 710P
Background
Repeated hepatectomy is the standard of care for resectable recurrent hepatocellular carcinoma (rHCC) whose recurrence rate remains higher than primary HCC. Moreover, there is no solid perioperative therapy for rHCC. This trial aims to assess the efficacy and safety of neoadjuvant tislelizumab in rHCC patients.
Methods
This is an ongoing phase II trial that enrolled resectable rHCC patients after curative treatment with two non-randomized separate arms (Arm 1: neoadjuvant tislelizumab; Arm 2: neoadjuvant tislelizumab and lenvatinib). When arm 1 completes enrollment, arm 2 initiates. In arm1, patients received two cycles of neoadjuvant tislelizumab 200mg intravenously every 3 weeks followed by hepatectomy and then received maximum 17 cycles of adjuvant tislelizumab within a year. The primary endpoint was 1-year disease-free survival rate, and secondary endpoints were objective response rate (ORR) assessed by RECIST 1.1, major pathologic response (>90% tumor necrosis), and safety.
Results
Between Jan 2021 and Sep 2021, 11 patients were enrolled in arm 1 and here we reported results of arm 1. All patients received neoadjuvant tislelizumab and underwent hepatectomy. No severe adverse events were observed and 4 patients developed adverse events of any grade during neoadjuvant treatment period. The most common adverse events of any grade were pruritus (in two patients), rash (in two) and fatigue (in one). No patients delayed surgery due to treatment-related adverse events. The ORR was 18.2% (2/11) with one achieving complete response and one achieving partial response. One patient developed progression with enlarging liver lesion and newly lung and bone metastases. And all the other patients remained stable disease. Regarding pathological response, two patients achieved tumor necrosis over 70%, with complete response in one, and 85% of necrosis in another. The other patients had pathologic response of 5-35%. Until Mar 20th 2022, 2 patients developed recurrence.
Conclusions
This is the first trial demonstrating the good safety and modest efficacy of neoadjuvant tislelizumab for rHCC patients, and we expect the efficacy of combining tislelizumab with lenvatinib in the ongoing arm 2.
Clinical trial identification
NCT04615143.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
The work is supported by the National Science Fund for Distinguished Young Scholars (No. 81825013), the National Natural Science Foundation of China (No. 82172047), the Guangdong Natural Science Foundation of Distinguished Youth Scholar (No. 2022B1515020060), the Kelin Outstanding Young Scientist of the First Affiliated Hospital, Sun Yat-sen University (R08030).
Disclosure
All authors have declared no conflicts of interest.