Background/Objectives: Advanced hepatocellular carcinoma (HCC) presents limited treatment options; however, immunotherapy demonstrates encouraging outcomes and acceptable adverse reactions in advanced HCC. This study evaluates the efficacy and safety of combining serplulimab, the bevacizumab biosimilar HLX04, and hepatic arterial infusion chemotherapy (HAIC) as a first-line therapy. Methods: This prospective, observational, single-center phase II trial enrolled untreated HCC patients with Barcelona Clinic Liver Cancer (BCLC) stage C. All patients received serplulimab (4.5 mg/kg) and HLX04 (15.0 mg/kg) every 3 weeks, followed by the HAIC-FOLFOX regimen. The primary endpoint was the objective response rate (ORR). Secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), and safety. Results: A total of 32 patients were enrolled. The best outcomes showed an ORR of 53.1%, including 17 partial responses (PR, 53.1%) and 12 stable diseases (SD, 37.5%), resulting in a DCR of 90.6%. Subgroup analysis showed a higher ORR in patients with a single lesion and those receiving ≥3 treatment cycles, with an ORR of 60.7% in the latter group. Additionally, five patients underwent successful hepatectomy after ≥3 treatment cycles, with postoperative pathology confirming extensive tumor necrosis. Kaplan–Meier analysis estimated PFS rates of 89.9% (95% CI: 79.5–100.0%) at 6 months and 70.8% (95% CI: 54.2–92.4%) at 12 months. No deaths related to adverse events (AEs) occurred; four (12.5%) patients experienced grade IV AEs and twelve (37.5%) patients experienced grade III AEs. Conclusions: Serplulimab, HLX04, and HAIC combined as a first-line treatment for advanced HCC have demonstrated promising efficacy, particularly in patients completing ≥3 cycles, with an acceptable safety profile. Further investigation in larger trials is required.
背景/目的：晚期肝细胞癌（HCC）的治疗选择有限，而免疫疗法在晚期HCC中显示出令人鼓舞的疗效和可接受的不良反应。本研究评估了斯鲁利单抗、贝伐珠单抗生物类似药HLX04联合肝动脉灌注化疗（HAIC）作为一线治疗的疗效与安全性。方法：这项前瞻性、观察性、单中心II期试验纳入了未经治疗的巴塞罗那临床肝癌（BCLC）C期HCC患者。所有患者每3周接受斯鲁利单抗（4.5 mg/kg）和HLX04（15.0 mg/kg）治疗，随后接受HAIC-FOLFOX方案。主要终点是客观缓解率（ORR）。次要终点包括疾病控制率（DCR）、无进展生存期（PFS）和安全性。结果：共纳入32例患者。最佳疗效显示ORR为53.1%，其中部分缓解（PR）17例（53.1%），疾病稳定（SD）12例（37.5%），DCR达90.6%。亚组分析显示，单发病灶患者及接受≥3个治疗周期的患者ORR更高，后者ORR达60.7%。此外，5例患者在完成≥3个治疗周期后成功接受肝切除术，术后病理证实肿瘤广泛坏死。Kaplan-Meier分析估计6个月PFS率为89.9%（95% CI：79.5–100.0%），12个月PFS率为70.8%（95% CI：54.2–92.4%）。未发生与不良事件（AEs）相关的死亡；4例（12.5%）患者出现IV级AEs，12例（37.5%）患者出现III级AEs。结论：斯鲁利单抗、HLX04联合HAIC作为晚期HCC的一线治疗方案显示出良好的疗效，尤其在完成≥3个治疗周期的患者中，且安全性可接受。仍需更大规模的试验进一步验证。
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