954P - Radiotherapy combined with tislelizumab plus anlotinib as first-line treatment for hepatocellular carcinoma: A single arm, phase II clinical trial

Background

The combination of PD-1 blockades with antiangiogenic drugs is the main therapeutic regimen for advanced hepatocellular carcinoma (HCC). Radiotherapy has generally been used to treat HCC with improved long-term outcome. The combination of radiotherapy and other therapies is considered to be a promising treatment for HCC. The objective of this study is to investigate the feasibility and safety of radiotherapy combined with tislelizumab plus anlotinib in advanced HCC.

Methods

In this single-center, open-label, phase II clinical trial, 45 patients(pts) with previously untreated, advanced HCC, with an age ranging from 18-75 years old, and an ECOG performance status ≤ 1 were planned to be enrolled. According to mRECIST efficacy evaluation criteria, the efficacy was evaluated by enhanced CT or MRI. RTOG/EORTC criteria was used to evaluate radiation-induced liver injury. Requirements for radiotherapy planning were D95% ≥14.2-46 Gy and ≥12.5-40 Gy for GTV and CTV, respectively. The patients underwent treatment with tislelizumab (200 mg, Q3W) plus anlotinib (8 mg, Q3W), and radiotherapy until disease progression or intolerance. The primary endpoints were ORR and OS, the secondary endpoints were PFS, DCR and safty.

Results

At data cut-off date of Feb 2023, 45 pts (44 males and 1 female) were enrolled with a median age of 51.5 years (range: 26-75). Of whom, 4 pts achieved complete response, 22 pts obtained partial response, 8 pts were stable disease, illustrating an ORR of 57.8% (95%CI 42.2-72.3) and a DCR of 75.6% (95%CI 60.5-87.1). The median PFS was 7.8 months (95%CI 5.8-9.8). The rate of treatment emerged adverse events (TEAEs) on grade 1/2 were 82.2%, and grade 3/4 were 13.3% (6/45). No grade 5 or radiation-induced liver disease were observed.

Conclusions

Radiotherapy combined with tislelizumab plus anlotinib demonstrated promising efficacy and tolerable safety profile in the treatment of advanced HCC. And this study was still ongoing and further follow-up was required to obtain final survival results subsequently.

Clinical trial identification

ChiCTR2000039022.

Editorial acknowledgement

Legal entity responsible for the study

the affiliated hospital of southwest medical university.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.