Tislelizumab in combination with anlotinib as first-line treatment for unresectable hepatocellular carcinoma: A single-arm, phase II clinical trial.

Abstract

576 Background: The inability to perform liver resection is an important cause of high mortality in Hepatocellular carcinoma (HCC) patients. Based on the clinical data of anlotinib (a multi-targeted tyrosine kinase inhibitor) and tislelizumab (anti‐PD‐1 antibody) in HCC pts, we therefore evaluated the safety and efficacy of tislelizumab plus anlotinib as first-line therapy for patients with unresectable HCC. Methods: Patients aged 18-75 years, with unresectable HCC, ECOG PS 0-3, BCLC stage A-D, Child-Pugh score A-C, and CNLC stage Ia-IV were enrolled. Patients who met the inclusion criteria received tislelizumab(intravenous drip, 200 mg/d1, Q3W) and anlotinib(oral, 8-12 mg/d1-14, Q3W). The primary endpoint was objective response rate (ORR). The secondary endpoints included disease control rate (DCR),overall survival (OS), progression-free survival (PFS), adverse events (AEs), and serious adverse events (SAEs). Results: Between Sep-2020 until Sep-2022, 37 patients were enrolled, and 25 patients’ clinical data were available to assess clinical efficacy. The median age of the pts was 62 years (ranged 31-72 years), 15 pts (60%) ECOG PS 1, 14 pts (56%) BCLC stage C, 17 pts (68%) Hepatitis B Virus Infection and 13 pts (52%) had received prior local regional therapy. The ORR per mRECIST was 32% (95% CI, 12.3%-51.7%) and DCR was 72% (95% CI, 53.1%-90.9%). The best clinical response was CR in 2 pts (8%), 6 pts (24%) PR and 10 pts (40%) SD. With a median follow-up of 12.7 months, the estimated median PFS was 11.8 months, and the median OS was not reached. The most common AEs during follow-up were AST increased (52%), γ-GT increased (48%), and hypoalbuminemia (48%). Conclusions: Tislelizumab combined with anlotinib showed high antitumor activity and good tolerability in the treatment of unresectable HCC, which may be an effective and safe treatment option.

Neoadjuvant therapies in resectable hepatocellular carcinoma: Exploring strategies to improve prognosis

“…(1) Anti-PD-1 antibody combined with TKIs In a study of 24 patients with resectable HCC receiving NAT with tislelizumab combined with lenvatinib, 17 patients (70.8%) underwent R0 resection, a pCR was achieved in 17.6%, and an MPR was achieved in 35.3% (necrosis >70%) (50). After undergoing NAT with nivolumab combined with cabozantinib, R0 resection was successfully performed in approximately 85.7% of patients.…”