Abstract 239P
Background
Hepatocellular carcinoma (HCC) has a high risk of recurrence after resection. Emerging evidence has shown that immune checkpoint inhibitors in the adjuvant setting are efficient in preventing or delaying HCC recurrence following curative resection. This study evaluated the efficacy and safety of adjuvant TACE combined with tislelizumab (a PD-1 inhibitor) for patients with resected HCC at high risk of recurrence (NCT04981665). Herein, the preliminary analysis results were reported.
Methods
In this phase II trial, postoperative HCC patients with at least one of the high-risk factors for recurrence were recruited from 6 medical centers in China. The high-risk factors included solitary tumor＞5 cm, solitary tumor＞2cm and ≤5cm with microvascular invasion (MVI), or 2∼3 lesions. Enrolled patients received 1 cycle of TACE 4±1 weeks after resection, followed by intravenous 200 mg tislelizumab every 3 weeks for 17 cycles. The primary endpoint was 2-year recurrence-free survival (RFS) rate. Secondary endpoints included RFS, time to recurrence, OS, 1-year RFS rate, 1-year and 2-year OS rate, and safety.
Results
A total of 50 eligible patients were enrolled, with a median age of 59 years (range 32-75). Forty-five (90%) patients had HBV infection. 50% had solitary tumor ＞5 cm, 32% had solitary tumor ＞ 2 cm and ≤ 5 cm with MVI, and 18% had 2-3 lesions. After a median follow-up duration of 17.5 months (data cut-off date, March 7, 2024), the 2-year RFS rate (primary endpoint) was not mature. The 1-year RFS rate was 86.6% (95% CI 72.5- 93.7), and the 1-year OS rate was 94.9% (95% CI 81.0- 98.7). Median RFS and OS were not reached. Treatment-emergent adverse events (TEAEs) occurred in 42 (84.0%) patients, and grade ≥3 TEAEs occurred in 9 (18.0%) patients. AE led to treatment discontinuation in 6 patients (12.0%). No AE-related death occurred.
Conclusions
Adjuvant TACE combined with tislelizumab yielded clinically promising efficacy with a tolerable safety profile in HCC patients with high risk of recurrence. Continued follow-up is ongoing to assess the long-term efficacy and safety of this combination strategy.
Clinical trial identification
NCT04981665.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.