KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
Int J Environ Res Public Health. 2023 Mar 3;20(5):4507. doi: 10.3390/ijerph20054507.
Cancer immunotherapy with immune checkpoint inhibitors (ICIs) is a major treatment option for several types of cancer, including non-small cell lung cancer (NSCLC). The proposed study aims to investigate the safety and efficacy of (BJIKT) therapy (an herbal medicine) in patients with advanced NSCLC treated with ICIs. This multicenter, randomized, placebo-controlled pilot study will be performed at three academic hospitals. Thirty patients with advanced NSCLC, undergoing atezolizumab monotherapy as second- and subsequent-line treatment, will be recruited and randomly assigned to either BJIKT treatment (atezolizumab + BJIKT) or placebo (atezolizumab + placebo). The primary and secondary outcomes are the incidence of adverse events (AEs), including immune- related AEs (irAEs) and non-immune-related AEs (non-irAEs); and early termination rate, withdrawal period, symptom improvement of fatigue, and skeletal muscle loss, respectively. The exploratory outcomes are patient objective response rate and immune profile. This is an ongoing trial. Recruitment started on 25 March 2022 and is expected to be completed by 30 June 2023. This study will provide basic evidence for the safety profiles, including irAEs, of herbal medicine in patients with advanced NSCLC treated with ICIs.
癌症免疫疗法中的免疫检查点抑制剂（ICI）是多种癌症的主要治疗选择，包括非小细胞肺癌（NSCLC）。本研究旨在探讨（BJIKT）疗法（一种草药）在接受 ICI 治疗的晚期 NSCLC 患者中的安全性和疗效。这是一项多中心、随机、安慰剂对照的初步研究，将在三家学术医院进行。将招募 30 名接受阿替利珠单抗单药二线及以上治疗的晚期 NSCLC 患者，并随机分为 BJIKT 治疗组（阿替利珠单抗+BJIKT）和安慰剂组（阿替利珠单抗+安慰剂）。主要和次要结局分别为不良事件（AE）的发生率，包括免疫相关 AE（irAE）和非免疫相关 AE（非 irAE）；以及早期终止率、退出期、疲劳和骨骼肌损失症状的改善。探索性结局为患者的客观缓解率和免疫谱。这是一项正在进行的试验。招募于 2022 年 3 月 25 日开始，预计于 2023 年 6 月 30 日完成。本研究将为接受 ICI 治疗的晚期 NSCLC 患者提供草药安全性特征（包括 irAE）的基础证据。
