Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
China Academy of Chinese Medical Sciences, Beijing, China.
Trials. 2021 Mar 17;22(1):214. doi: 10.1186/s13063-021-05169-w.
Non-small-cell lung cancer (NSCLC) is usually diagnosed at an advanced stage, and chemotherapy is the main treatment for this disease. Kanglaite injections (KLTi) have been widely used for the treatment of cancer in China. KLTi combined with chemotherapy could improve the short-term efficacy, quality of life, and performance status for NSCLC compared with chemotherapy alone. This trial aims to assess the long-term efficacy and safety of KLTi in combination with chemotherapy for the treatment of advanced NSCLC.
This will be an investigator-initiated multicenter open-label randomized controlled trial. We will randomly assign 334 eligible participants with stage IIIA-IV NSCLC to the treatment or control groups in a 1:1 ratio. Patients in both groups will be administered 4-6 cycles of first-line platinum-based double chemotherapy regimens. Patients with complete response, partial response, or stable disease after 4-6 cycles will receive non-platinum single-agent chemotherapy. Patients in the treatment group are to receive intravenous KLTi 200 ml per day continuously for 14 days, commencing on the first day of chemotherapy. The treatment will be discontinued at the time of disease progression or until unacceptable toxicity is noted. The follow-up will be conducted every 2 months until death, loss of follow-up, or 12 months from randomized enrollment. The primary outcome will be progression-free survival (PFS). The secondary outcomes will be the objective response rate, 1-year survival rate, quality of life, living ability, and blood lipids. The safety outcome will be the rate of adverse events.
This study will be the first randomized controlled trial in which PFS is used as the primary outcome to test whether KLTi combined with first-line chemotherapy has superior efficacy and reduced toxicity compared to chemotherapy alone in advanced NSCLC. This will also be the first clinical study to observe the effects of KLTi on blood lipids.
ClinicalTrials.gov NCT03986528 . Prospectively registered on 30 May 2019.
非小细胞肺癌（NSCLC）通常在晚期诊断，化疗是该病的主要治疗方法。康莱特注射液（KLTi）在中国已广泛用于癌症治疗。KLTi 联合化疗与单纯化疗相比，可提高 NSCLC 的短期疗效、生活质量和功能状态。本试验旨在评估 KLTi 联合化疗治疗晚期 NSCLC 的长期疗效和安全性。
这将是一项由研究者发起的多中心、开放性、随机对照试验。我们将按 1:1 的比例将 334 名符合条件的 IIIA-IV 期 NSCLC 患者随机分配到治疗组或对照组。两组患者均接受 4-6 个周期的一线含铂双化疗方案。4-6 个周期后完全缓解、部分缓解或病情稳定的患者接受非铂类单药化疗。治疗组患者接受静脉滴注 KLTi，每天 200ml，连续 14 天，从化疗第一天开始。疾病进展或出现不可耐受的毒性时停止治疗。随访每 2 个月进行一次，直至死亡、失访或随机入组后 12 个月。主要终点为无进展生存期（PFS）。次要终点为客观缓解率、1 年生存率、生活质量、生活能力和血脂。安全性终点为不良事件发生率。
本研究将是首个以 PFS 为主要终点的随机对照试验，旨在检验 KLTi 联合一线化疗与单纯化疗相比，在晚期 NSCLC 中是否具有更好的疗效和降低毒性。这也将是首个观察 KLTi 对血脂影响的临床研究。
ClinicalTrials.gov NCT03986528。于 2019 年 5 月 30 日前瞻性注册。
