Zheng Jiyang, Wang Shu, Xu Guanghui, Wang Juan, Wang Yuhao, Luo Jialin, Wang Yan, Yang Jianjun
Department of Digestive Surgery, Xijing Hospital, The Fourth Military Medical University, Xi'an, China.
Department of Gastroenterology, Xijing 986 Hospital, The Fourth Military Medical University, Xi'an, China.
J Gastrointest Oncol. 2023 Apr 29;14(2):1131-1140. doi: 10.21037/jgo-23-131. Epub 2023 Apr 27.
Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is an optimized and improved derivative of paclitaxel with superior efficacy and fewer adverse reactions, and it is widely used in the treatment of advanced gastric cancer. However, there is a paucity of data regarding the safety and efficacy of nab-paclitaxel combined with oxaliplatin (LBP) and tegafur in the treatment of patients with advanced gastric cancer.
This analysis is a prospective, single-center, open-label, historically controlled real-world study designed to include 10 patients with advanced gastric cancer treated with nab-paclitaxel combined with LBP and tegafur gimeracil oteracil potassium. The primary and main efficacy outcomes are safety indicators, including the incidence of adverse drug reactions and adverse events (AEs), as well as the outliers of laboratory indicators and vital signs. The secondary efficacy outcomes are overall survival (OS), objective response rate (ORR), disease control rate (DCR), and proportion of dose suspensions, dose reductions and discontinuations.
Based on the findings of previous studies, we wished to assess the safety and efficacy of nab-paclitaxel combined with LBP and tegafur in the treatment of advanced gastric cancer. The trial requires constant contact and monitoring. The purpose is to determine a superior protocol in terms of patient survival, and pathological and objective response.
This trial has been registered with the Clinical Trial Registry: NCT05052931 (registration date: 2021/9/12).
纳米白蛋白结合型紫杉醇（nab-紫杉醇）是紫杉醇的一种优化改进衍生物，疗效更佳且不良反应更少，广泛应用于晚期胃癌治疗。然而，关于nab-紫杉醇联合奥沙利铂（LBP）和替吉奥治疗晚期胃癌患者的安全性和疗效的数据较少。
本分析是一项前瞻性、单中心、开放标签、历史对照的真实世界研究，旨在纳入10例接受nab-紫杉醇联合LBP和替吉奥治疗的晚期胃癌患者。主要疗效指标为安全性指标，包括药物不良反应和不良事件（AE）的发生率，以及实验室指标和生命体征的异常值。次要疗效指标为总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）以及剂量中断、剂量减少和停药的比例。
基于既往研究结果，我们希望评估nab-紫杉醇联合LBP和替吉奥治疗晚期胃癌的安全性和疗效。该试验需要持续的联系和监测。目的是在患者生存、病理和客观反应方面确定一个更优方案。
本试验已在临床试验注册中心注册：NCT05052931（注册日期：2021/9/12）。
