Guangzhou University of Chinese Medicine, Guangzhou, China.
Guangzhou University of Traditional Chinese Medicine First Affiliated Hospital, Guangzhou, China.
Integr Cancer Ther. 2023 Jan-Dec;22:15347354221151147. doi: 10.1177/15347354221151147.
Anlotinib is used as a third-line treatment for advanced non-small-cell lung cancer (NSCLC), but has limited clinical benefits and several side effects, such as diarrhea and acneiform skin rash. Traditional Chinese Medicine (TCM) is commonly used to treat cancers in China. Chinese herbal medicines may have the potential as adjuvant therapies to reduce toxicity and improve the efficacy of treatments for NSCLC. Given the positive outcomes of basic research, we plan to evaluate whether the addition of the Chinese herbal medicine Yifei Sanjie formula (YFSJF) to anlotinib can improve the progression-free survival (PFS) of advanced NSCLC patients.
A multicenter, randomized, double-blind, placebo-controlled parallel-group controlled pilot trial will be performed. Forty eligible patients will be randomized in a ratio of 1:1 to the intervention (YFSJF + anlotinib) and control (placebo + anlotinib) groups. Participants will be advised to take 12 mg/day of anlotinib on days 1 to 14 of each 21-day cycle. YFSJF or placebo will be administered (15 g twice daily) during each cycle until progression of disease (PD). The primary outcome will be progression-free survival (PFS), and the secondary outcomes will be overall survival (OS), the objective response rate (ORR), and patient-reported outcomes (PRO). Tumors will be assessed based on RECIST v. 1.1 after every 2 cycles of treatment. The M. D. Anderson Symptom Inventory-Lung Cancer (MDASI-LC) will be used to evaluate PRO at baseline and weekly thereafter until PD.
This will be the first trial to evaluate the effectiveness and safety of TCM combined with anlotinib for the treatment of NSCLC. The results of this randomized controlled trial will fill a gap in the research by showing whether YFSJF combined with anlotinib can improve PFS in NSCLC patients.
The study was registered on June 8th, 2021 on Chinese Clinical Registry; registration number ChiCTR2100047143. (https://www.chictr.org.cn/index.aspx).
The Ethics Committee of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine approved the study protocol (approval no.: K2020151, 2021/08/19). The study will also be supervised and managed by the Ethics Committee.
安罗替尼被用作晚期非小细胞肺癌（NSCLC）的三线治疗药物，但临床获益有限，且有多种副作用，如腹泻和痤疮样皮疹。中药在中国常用于治疗癌症。中草药可能具有作为辅助疗法的潜力，以降低毒性并提高 NSCLC 治疗的疗效。鉴于基础研究的积极成果，我们计划评估在安罗替尼中添加中药益肺散结方（YFSJF）是否能改善晚期 NSCLC 患者的无进展生存期（PFS）。
将进行一项多中心、随机、双盲、安慰剂对照的平行分组对照试验。将 40 名符合条件的患者以 1:1 的比例随机分为干预组（YFSJF+安罗替尼）和对照组（安慰剂+安罗替尼）。建议参与者在每个 21 天周期的第 1 至 14 天每天服用 12mg 安罗替尼。在每个周期中，YFSJF 或安慰剂将在疾病进展（PD）之前（每天两次，每次 15g）给药。主要终点是无进展生存期（PFS），次要终点是总生存期（OS）、客观缓解率（ORR）和患者报告的结局（PRO）。治疗每 2 个周期后，将根据 RECIST v.1.1 评估肿瘤。将使用 M.D.安德森症状清单-肺癌（MDASI-LC）在基线和 PD 之前每周评估 PRO。
这将是第一项评估中药联合安罗替尼治疗 NSCLC 的有效性和安全性的试验。这项随机对照试验的结果将填补研究空白，表明 YFSJF 联合安罗替尼是否能改善 NSCLC 患者的 PFS。
该研究于 2021 年 6 月 8 日在中国临床试验注册中心注册；注册号 ChiCTR2100047143（https://www.chictr.org.cn/index.aspx）。
广州中医药大学第一附属医院伦理委员会批准了该研究方案（批准号：K2020151，2021/08/19）。该研究还将受到伦理委员会的监督和管理。
