Efficacy of Callispheres-TACE in combination with Sindillimab for unresectable hepatocellular carcinoma

Abstract

Abstract: Objective To evaluate the effectiveness of combining Callispheres-hepatic arterial chemoembolization (TACE) with sindillimab in the management of unresectable hepatocellular carcinoma. Methods A total of 110 patients with unresectable hepatocellular carcinoma were admitted to our hospital from January 2020 to January 2022. They were randomly divided into the control group or the observation group, with 55 patients in each group. The control group received Callispheres-TACE treatment, while the observation group received Callispheres-TACE combined with sindillimab. The levels of tumor markers [alpha-fetoprotein (AFP), CA242, CA724], tumor growth factors [basic fibroblast growth factor (bFGF) vascular endothelial growth factor (VEGF)], anti-tumor immune response factors [CD3⁺, CD4⁺, CD8⁺, CD4⁺/CD8⁺], oncogenes [proliferation-related genes (C-myc), fibroblast growth factor 2 (FGF2)] and tumor suppressor genes [cell cycle dependent protein kinase inhibitor (P16), iron apoptotic protein (Hepcidin)] were compared between the two groups. Furthermore, a comparative analysis of the recent treatment efficacy, adverse reactions, and survival status was conducted between the two groups. Results After treatment, the observation group demonstrated significantly lower AFP, CA242 and CA724 (405.12±40.86 μg/L, 6.57±1.02 U/mL, 13.34±3.08 U/mL, respectively), compared to the control group (557.56±67.45μg/L, 9.69±1.63 U/mL and 16.34±3.69 U/mL), with statistically significant differences (t=14.340, 12.108, 8.377, P<0.05). Similarly, the levels of bFGF and VEGF in the observation group (3.64±0.57 pg/mL and 155.71±15.72 pg/mL) were significantly lower than those in the control group (6.33±0.86 pg/mL and 221.46±36.33 pg/mL), with statistically significant differences (t=19.340, 12.320, P<0.05). Furthermore, the observation group exhibited higher levels of CD3⁺, CD4⁺, and CD4⁺/CD8⁺ (68.31±7.42%, 44.12±5.13% and 1.58±0.26) and a lower level of CD8⁺ (21.24±2.01%) when compared to the control group (56.43±6.36%, 36.35±4.20%, 1.25±0.14, and 26.34±2.71%, respectively), and the difference was statistically significant (t=9.015, 8.691, 11.210, 8.288, all P<0.05). The levels of C-myc and FGF2 in the observation group (1.09±0.14 pg/mL and 1.21±0.25 pg/mL, respectively) were also lower than those in the control group (6.75±1.22 pg/mL and 5.78±1.33 pg/mL) while the levels of P16 and Hepcidin in the observation group (11.42±0.83 pg/mL and 12.95±1.27 pg/mL) were higher than those in the control group (7.45±0.98 pg/mL and 8.42±1.35 pg/mL). The difference was statistically significant (t=34.180, 25.040, 22.930, 18.130, all P<0.05). The observation group achieved a higher objective response rate (ORR) of 80.00% compared to the control group’s 61.82% (P<0.05). However, there was no significant difference in the incidence of adverse reactions between the two groups (P>0.05). Additionally, the observation group demonstrated longer median progression-free survival time, median overall survival time, and 12-month survival rate (8.12±1.09 months, 10.35±1.04 months and 72.73%, respectively), compared to the control group (6.84±0.87 months, 8.98±1.43 months, 52.73%) (t=6.807, 5.823, 4.705, all P<0.05). Conclusion The combination of Callispheres-TACE and Sindillimab shows promise in inhibiting lesion growth, restoring the expression imbalance of oncogenes and tumor suppressor genes, and improving survival outcomes in patients with unresectable hepatocellular carcinoma, thereby enhancing short-term efficacy.

Key words: Hepatocellular carcinoma, Callispheres-Hepatic arterial chemoembolization, Sinilizumab, Life cycle

ZHANG Yong-hong, CHU Jian-hua, CHEN Guo-dong. Efficacy of Callispheres-TACE in combination with Sindillimab for unresectable hepatocellular carcinoma[J]. Chinese Hepatolgy, 2024, 29(2): 202-207.

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