PDF(Pubmed)
Abstract：
UNASSIGNED: Exposing tumor antigens to the immune system is the key to ensuring the efficacy of immunotherapy. SBRT is the main way to reveal the specifical antigens of tumors which can enhance the immune response. We aimed to explore the clinical efficacy and safety of Toripalimab combined with Anlotinib for uHCC after SBRT.
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.
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.
摘要：
■将肿瘤抗原暴露于免疫系统是确保免疫疗法疗效的关键。SBRT是揭示肿瘤特异性抗原的主要途径，可以增强免疫应答。我们旨在探讨托里帕利马联合安洛替尼治疗SBRT术后uHCC的临床疗效和安全性。
■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。
■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。
