Abstract:

Objective To analysis the efficacy and tolerability of sintilimab in combination with lenvatinib therapy as second ⁃line regimen for patients with hepatocellular carcinoma（HCC）. Methods We retrospectively analyzed the data of 39 patients with unresectable HCC treated with sintilimab in combination with lenvatinib as second⁃line therapy，as well as the data of another 36 patients treated with lenvatinib therapy as contrast. The clinical data such as the baseline data from blood routine test liver function test，renal function test tumor staging，tumor imaging features，previous treatment strategies，follow ⁃ up imaging results and adverse events during follow ⁃ ups were recorded. The Modified Response Evaluation Criteria in Solid Tumors was used to evaluate the treatment out⁃ come of intrahepatic lesions and the Kaplan⁃Meier method was used to evaluate survival time. Results All through the follow⁃ups，the treatments for the patients from both groups did not reached complete response. Among the 39 patients treated with sintilimab plus lenvatinib，15 cases achieved partial remission（PR），accounting for 38.4%， 14 disease stability（DS），accounting for 35.9% ，and 10 progressive disease，accounting for 25.8%，with the ORR and DCR of 38.5% and 74.4%，respectively. Among the 36 patients in the control group，6 cases achieved partial remission，accounting for 16.7%，14 disease stability，accounting for 35.8%，and 10 progressive disease，accounting for 25.8%，with the ORR and DCR of 38.5% and 74.4%，respectively. The median progression⁃free survival（PFS） was 9.1 months in the combination group（95%CI：7.5 ~ 10.7）and 5.9 months（95%CI：4.7 ~ 7.1）in the control group，with a statistically significant difference between the two groups（P < 0.001）. Median Overall Survival（OS） time in the combination group was 18.4 months（95%CI：16.5 ~ 20.3）and 11.6 months（95%CI：7.2 ~ 16.0）in the control group，with a statistical difference between the two groups（P = 0.016）. Grade ≥ 3 treatment ⁃related ad⁃ verse events （TRAEs） included hypertension and diarrhea. All TRAEs were effectively controlled. Conclu⁃ sion Sintilimab combined with lenvatinibcan yield a promising outcome in treating the patients with unresectable HCC for its low incidence rate of serious adverse eventsand thus it is a safe and effective treatment regimen.

Key words:

hepatocellular carcinoma, sintilimab, lenvatinib, safety, efficacy