Published online Jun 28, 2023. doi: 10.3748/wjg.v29.i24.3871
Peer-review started: March 26, 2023
First decision: April 26, 2023
Revised: May 6, 2023
Accepted: May 30, 2023
Article in press: May 30, 2023
Published online: June 28, 2023
Processing time: 94 Days and 9.2 Hours
Stereotactic body radiotherapy (SBRT) and programmed cell death 1 inhibitors have shown potential in treating hepatocellular carcinoma (HCC) in retrospective studies.
To evaluate the efficacy of combining SBRT with sintilimab for patients with recurrent or oligometastatic HCC.
This trial involved patients with recurrent or oligometastatic HCC intravenously treated with SBRT plus sintilimab every 3 wk for 12 mo or until disease pro
Twenty-five patients were enrolled from August 14, 2019, to August 23, 2021. The median treatment duration was 10.2 (range, 0.7-14.6) months. SBRT was delivered at a median dose of 54 (range, 48-60) Gy in 6 (range, 6-10) fractions. The median follow-up time was 21.9 (range, 10.3-39.7) mo, and 32 targeted lesions among 25 patients were evaluated for treatment response according to the Response Evaluation Criteria in Solid Tumors version 1.1. The median PFS was 19.7 mo [95% confidence interval (CI): 16.9-NA], with PFS rates of 68% (95%CI: 52-89) and 45.3% (95%CI: 28-73.4) at 12 and 24 mo, respectively. The median overall survival (OS) was not reached, with OS rates of 91.5% (95%CI: 80.8-100.0) and 83.2% (95%CI: 66.5-100.0) at 12 and 24 mo, respectively. The 1- and 2-year local control rate were 100% and 90.9% (95%CI: 75.4%-100.0%), respectively. The confirmed objective response rate and disease control rate was 96%, and 96%, respectively. Most adverse events were graded as 1 or 2, and grade 3 adverse events were observed in three patients.
SBRT plus sintilimab is an effective, well-tolerated treatment regimen for patients with recurrent or oligometastatic HCC.
Core Tip: In this single-arm phase II trial, stereotactic body radiotherapy (SBRT) plus sintilimab showed outstanding progression-free survival and objective response rate in the treatment of recurrent or oligometastatic hepatocellular carcinoma. Moreover, the combined use of SBRT and sintilimab is safe and tolerable. Patients can recover rapidly from radiotherapy-induced decreases in lymphocyte counts. This result suggests that SBRT combined with sintilimab may be a new treatment option for patients with recurrent or oligometastatic hepatocellular carcinoma.