UNASSIGNED: This is a prospective, single-arm, explorative clinical study. uHCC patients with an ECOG PS score of 0-1, Child-Pugh class A or B, and BCLC stage B or C were included and treated with SBRT(8Gy*3) followed by 6-cycle combinational therapy with Toripalimab and Anlotinib. The primary endpoint was progression-free survival (PFS) and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), and incidence of treatment-related adverse events (TRAEs). Continuous variables were presented as medians and ranges. Survivals were studied with the Kaplan-Meier method. Categorical data were expressed as n (percentage).
UNASSIGNED: Between June 2020 and October 2022, a total of 20 patients with intermediate-advanced uHCC were enrolled. All cases had multiple intrahepatic metastases, or macrovascular invasion, or both, among whom 5 cases with lymph node or distant metastases. Until September 2022, the median follow-up time was 7.2 months (range, 1.1-27.7 months). Median survival time could not be assessed at the moment, based on iRecist, median PFS was 7.4 months (range, 1.1-27.7 months), ORR 15.0%, and DCR 50.0%. 14 patients experienced treatment-related adverse events with an incidence of 70%. The overall survival rates at 18 months and 24 months were 61.1% and 50.9%, respectively. And the progression-free survival rates were 39.3% and 19.7%.
UNASSIGNED: Exposure of specific antigens of HCC via SBRT may improve the efficacy of combinational therapy with Toripalimab and Anlotinib for uHCC with manageable adverse effects, which deserves further exploration.
UNASSIGNED: www.clinicaltrials.gov, identifier ChiCTR2000032533.
■这是一个前景,单臂,探索性临床研究。ECOGPS评分为0-1,Child-PughA级或B级的uHCC患者,纳入B期或C期BCLC,接受SBRT(8Gy*3)治疗,随后接受托里帕利马和安洛替尼6个周期的联合治疗.主要终点是无进展生存期(PFS),次要终点是客观缓解率(ORR)。疾病控制率(DCR),总生存期(OS),和治疗相关不良事件(TRAEs)的发生率。连续变量以中位数和范围表示。用Kaplan-Meier方法研究存活。分类数据以n(百分比)表示。
■在2020年6月至2022年10月之间,共招募了20例中晚期uHCC患者。所有病例均有多发肝内转移,或者大血管侵犯,或者两者兼而有之,其中5例伴淋巴结或远处转移。截至2022年9月,中位随访时间为7.2个月(范围,1.1-27.7个月)。目前无法评估中位生存时间,根据iRecist,中位PFS为7.4个月(范围,1.1-27.7个月),ORR15.0%,和DCR50.0%。14例患者出现治疗相关不良事件,发生率为70%。18个月和24个月的总生存率分别为61.1%和50.9%,分别。无进展生存率分别为39.3%和19.7%。
■通过SBRT暴露HCC的特异性抗原可能会提高托里帕利马和安洛替尼联合治疗uHCC的疗效,不良反应可控,值得进一步探索。
■www.clinicaltrials.gov,标识符ChiCTR2000032533。