■观察和评估多纳非尼联合经动脉化疗栓塞(TACE)治疗不可切除的肝细胞癌(HCC)的疗效和安全性。
■这个前景,单臂,单中心,II期临床研究纳入了36例初次无法切除的HCC患者,这些患者未接受任何系统治疗.患者接受多纳非尼加TACE(n=26)或多纳非尼加TACE加程序性死亡受体1抑制剂(n=10)。主要终点是短期疗效,次要终点包括无进展生存期(PFS),响应时间(TTR)疾病控制率(DCR),和不良事件。还测量了肿瘤供血动脉直径。
■对所有36例患者的疗效评估显示6例完全缓解,19的部分反应,8稳定的疾病,和3进行性疾病。6名(16.7%)患者成功接受了转换手术,全部实现R0切除,2例(5.6%)达到完全病理反应。客观有效率(ORR)为69.4%,DCR为91.7%。中位PFS为10.7个月,未达到中位总生存期,TTR中位数为1.4个月.6、12和18个月的中位生存率为85.0%,77.6%,和71.3%,分别。6、12和18个月的中位PFS率为65.3%,45.6%,和34.2%,分别。治疗相关不良事件(TRAEs)发生在所有25名受试者中,包括4个(11.3%)3级TRAE。没有发生4级或5级TRAE。治疗后肿瘤供血动脉直径明显下降(P=0.036)。多变量分析显示基线目标病变直径的总和,最佳肿瘤反应,联合免疫疗法是PFS的独立预测因子。
■TACE加多纳非尼可降低不可切除HCC患者的肿瘤供血动脉直径。安全性很好,实现了较高的ORR。
UNASSIGNED: To observe and assess the
efficacy and safety of donafenib combined with transarterial chemoembolization (TACE) to treat unresectable hepatocellular carcinoma (HCC).
UNASSIGNED: This prospective, single-arm, single-center, phase II clinical study enrolled 36 patients with initial unresectable HCC who had not undergone any systemic treatment. The patients received donafenib plus TACE (n = 26) or donafenib plus TACE plus programmed death receptor 1 inhibitors (n = 10). The primary endpoint was short-term
efficacy, with secondary endpoints including progression-free survival (PFS), time to response (TTR), disease control rate (DCR), and adverse events. The tumor feeding artery diameter was also measured.
UNASSIGNED: Efficacy evaluation of all 36 patients revealed 6 cases of complete response, 19 of partial response, 8 of stable disease, and 3 of progressive disease. Six (16.7%) patients successfully underwent conversion surgery, all achieving R0 resection, and 2 (5.6%) achieved a complete pathological response. The objective response rate (ORR) was 69.4% and the DCR was 91.7%. The median PFS was 10.7 months, the median overall survival was not reached, and the median TTR was 1.4 months. The median survival rates at 6, 12, and 18 months were 85.0%, 77.6%, and 71.3%, respectively. The median PFS rates at 6, 12, and 18 months were 65.3%, 45.6%, and 34.2%, respectively. Treatment-related adverse events (TRAEs) occurred in all 25 subjects, including 4 (11.3%) grade 3 TRAEs. No grade 4 or 5 TRAEs occurred. The tumor feeding artery diameter was significantly decreased following treatment (P = 0.036). Multivariable analysis revealed the sum of baseline target lesion diameters, best tumor response, and combined immunotherapy as independent predictors of PFS.
UNASSIGNED: TACE plus donafenib reduced the tumor feeding artery diameter in patients with unresectable HCC. The safety profile was good, and a high ORR was achieved.