胆道癌(BTC)是一种异质性的、高度侵袭性的肿瘤，预后差，需要更有效的治疗。肿瘤免疫治疗在BTC中的作用尚不明确。BTC的肿瘤微环境(TME)是高度免疫抑制的，需要联合治疗以提高有效的抗癌免疫。血管内皮生长因子(VEGF)通过破坏抗原递呈、限制T细胞浸润或增强免疫抑制细胞，在TME中驱动免疫抑制。许多VEGF调控机制被认为与BTC抗肿瘤免疫抑制有关，同时靶向VEGF与PD-1/PD-L1途径成为一种合理的方法。
Courage cancer (BTC) is a heterogeneous, highly invasive tumor that requires more effective treatment. The role of oncological immunity treatment in BTC is unclear. The BTC's neoplasm micro-environment (TME) is highly immune inhibitive and requires joint treatment to improve effective anti-cancer immunization. The vascular internal growth factor (VEGF) drives immunisation in TIE by disrupting antigen delivery, limiting immersion of T-cells or increasing immunosuppressive cells. Many VEGF regulatory mechanisms are considered to be related to BTC's anti-cancer immunology inhibition, while targeting VEGF and the PD-1/PD-L1 route is a reasonable method.
靶免联合二线治疗胆道肿瘤已有数据
Target-free 2-line treatment for cerebral tumors is available.
安全可靠
Safe and secure.
LEAP- 005 (NCT03797326)正在评估仑伐替尼+帕博利珠单抗（“可乐”组合）在既往治疗过的晚期实体瘤患者中的有效性和安全性。ASCO会议上展示了LEAP-005研究的BTC队列的结果。
LEAP-005 (NCT03797326) is assessing the effectiveness and safety of the Lendeni + Paboliad Monopoly (the “Cola” combination) in patients with late-stage physical tumours that have been treated. The results of the BTC queue of the study LEAP-005 were presented at the ASCO meeting.
在这项非随机、开放标签的2期研究中，纳入了31例既往接受过1次治疗后疾病进展的晚期(转移性和/或不可切除)BTC患者。患者接受仑伐替尼20mg每日1次+帕博利珠单抗200mg 每3周一次治疗35个周期(约2年)。研究结果显示，ORR为10%，3例PRs，18例SD，DCR为68%。中位DOR为5.3个月。中位无进展生存期为6.1个月。中位OS为8.6个月。30例患者(97%)发生了治疗相关的不良事件，其中15例(48%)发生3级不良事件;没有4级或5级治疗相关的AEs。
In the second study, which was not random, open labeled, 31 cases of advanced (transferability and/or non-circumcision) BTC patients were included. The patient received 20 mg/day treatment of 20 mg/day + 200 mg/week (approximately two years). The results showed that the ORR was 10%, 3 PRs, 18 SDs, 68% DCRs. The median DOR was 5.3 months. The median no-progress period was 6.1 months. The median OS was 8.6 months.
可以看出，仑伐替尼+帕博利珠单抗在既往接受1线治疗的晚期BTC患者中显示出令人鼓舞的疗效和可管理的毒性。基于这些数据，BTC队列的登记已扩大到100名患者。
On the basis of these data, the registration of the BTC queue has been extended to 100 patients.
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