A prospective cohort study on the improvement of disease-free progression survival in patients with hepatocellular carcinoma by combining Sophora japonica granules with targeted and immune checkpoint inhibitors.

Abstract

e16187 Background: To evaluate the clinical efficacy of combining Sophora japonica granules with targeted therapy and immune checkpoint inhibitors (ICIs) in patients with unresectable hepatocellular carcinoma (HCC) who had not undergone systemic treatment. Methods: A prospective cohort study design was adopted (ChiCTR2400079626), collecting HCC patients visited the Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region from July 1, 2019, to July 1, 2023. All patients received targeted therapy and ICIs treatment. "Whether Sophora japonica granules were combined during treatment" was considered as the exposure factor. Patients who met this exposure factor were included in the exposure group (n = 48), and those who did not meet this factor were included in the non-exposure group (n = 44). The disease-free survival (PFS), six-month PFS rate, and subgroup analysis between two groups. Results: The PFS of the exposure group was 8.9 months (m), and that of the non-exposure group was 5m(P = 0.001 HR = 0.50, 95%CI (0.32~0.78)). The six-month PFS rates were 66.7% compared to 34.1%(P = 0.001). Subgroup analysis showed that in subgroups with hepatitis, cirrhosis, vascular invasion, extrahepatic metastasis, tumor maximum diameter ≥5cm, combined TKI, the exposure group had significantly longer PFS than the non-exposure group (respectively: 9m VS 5m, 10m VS 4m, 13m VS 3m, 8.3m VS 4m, 9m VS 4m, 9m VS 5m),(P < 0.05). In the subgroup with a history of alcohol consumption, the exposure group's PFS was extended by 9 m (14m VS 5m; P = 0.010); in the subgroup with baseline AFP ≥400ng/ml, PFS was extended by 6m (9m VS 3m; P = 0.017), and in the subgroup with baseline AFP < 400ng/ml, PFS was also extended by 2.9m (8.9m VS 6m; P = 0.024), with all differences being statistically significant. Multivariate analysis showed that extrahepatic metastasis was an independent prognostic factor, with a disease progression risk 1.77 times higher than that of patients without extrahepatic metastasis [HR = 1.77, 95%CI (1.11~2.81), P = 0.016]. Combining Sophora japonica granules was a protective factor [HR = 0.53, 95%CI (0.33~0.84), P = 0.006], reducing the risk of disease progression in HCC patients treated with targeted therapy and ICIs by 47%. Conclusions: Combining Sophora japonica granules can extend the progression-free survival of HCC patients treated with targeted therapy and ICIs, increase the six-month PFS rate, and significantly reduce the risk of disease progression. The survival benefit was more pronounced in subgroups with vascular invasion and a history of alcohol consumption, with PFS exceeding one year. After combining Sophora japonica granules, the survival benefit improved more in the ICIs + TKI subgroup compared to the ICIs + bevacizumab subgroup. Clinical trial information: ChiCTR2400079626.