953P - Tislelizumab plus regorafenib as second-line therapy for unresectable hepatocellular carcinoma (uHCC): A single-arm, phase II trial

Background

Second-line treatment options for patients with unresectable hepatocellular carcinoma (uHCC) are limited. Monotherapy with regorafenib or tislelizumab (an anti-PD-1 antibody) has shown clinical benefit for uHCC in the second-line setting. The present study explored the safety and efficacy of the tislelizumab plus regorafenib as second-line therapy for uHCC.

Methods

This was a single-arm, investigator-initiated phase II trial. Patients with confirmed uHCC were enrolled to receive tislelizumab (200mg, q3w) plus regorafenib (80mg-160mg, daily, 3 weeks on/1 week off, every 4 weeks). The primary endpoint was safety and tolerability; Secondary endpoints included overall response rates (ORR), progression-free survival (PFS), and disease control rate (DCR) per mRECIST.

Results

A total of 28 patients were enrolled with median age of 59 years (range: 40-76) and 96% were men. Most common etiology of HCC was hepatitis B (n=26, 93%). 54% of patients were Barcelona Clinic Liver Cancer stage C. 67.9% of patients received prior treatment with tyrosine kinase inhibitors (TKIs; sorafenib [50%] or lenvatinib [17.9%]), and 21.4% received TKIs plus PD-1 antibody. ORR was 28.6% and DCR was 71.4%, with 3 pts having CR, 5 PR, and 12 SD. At the data cut-off date, the median PFS of the 28 pts was 6.4 months (95%Cl 90%, NA)), and the median OS was not reached. The most common treatment-related adverse events at any grade were rash (6/28;21%), hypertension (9/28;32%), hand-foot syndrome (18/28;64%) and fatigue (7/28;25%), which were mostly grade 1 or 2 in severity.

Conclusions

This study indicated that tislelizumab plus regorafenib is an effective and well-tolerated therapeutic option for patients with uHCC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Xuetao Shi.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.