TeloVac 研究表明 GV1001 并未改善晚期胰腺导管腺癌 (PDAC) 的生存率。然而，细胞因子检查表明，高血清嗜酸细胞趋化因子水平可能预测对 GV1001 的反应。这项 III 期试验评估了 GV1001 联合吉西他滨/卡培他滨治疗未经治疗的晚期 PDAC 的嗜酸细胞趋化因子高患者的疗效。从 16 家医院招募的患者接受了吉西他滨（1000mg/m2，D 1、8 和 15）/卡培他滨（830mg/ m2 BID，持续 21 天）每月随机使用（GV1001 组）或不使用（对照组）GV1001（0.56mg；D 1、3 和 5，第 2-4、6 周一次，然后每月一次） 1：1的比例。主要终点是总生存期 (OS)，次要终点包括进展时间 (TTP)、客观缓解率和安全性。总共 148 名患者被随机分配到 GV1001 (n = 75) 和对照组 (n = 73) 。与对照组相比，GV1001 组的中位 OS（11.3 个月与 7.5 个月，P = 0.021）和 TTP（7.3 个月与 4.5 个月，P = 0.021）有所改善。 GV1001 组和对照组的 3 级以上不良事件发生率分别为 77.3% 和 73.1%（P = 0.562）。在嗜酸细胞趋化因子高的晚期 PDAC 患者中，与单用吉西他滨/卡培他滨相比，GV1001 加吉西他滨/卡培他滨可改善 OS 和 TTP .NCT02854072.© 2023。作者。

The TeloVac study indicated GV1001 did not improve the survival of advanced pancreatic ductal adenocarcinoma (PDAC). However, the cytokine examinations suggested that high serum eotaxin levels may predict responses to GV1001. This Phase III trial assessed the efficacy of GV1001 with gemcitabine/capecitabine for eotaxin-high patients with untreated advanced PDAC.Patients recruited from 16 hospitals received gemcitabine (1000 mg/m2, D 1, 8, and 15)/capecitabine (830 mg/m2 BID for 21 days) per month either with (GV1001 group) or without (control group) GV1001 (0.56 mg; D 1, 3, and 5, once on week 2-4, 6, then monthly thereafter) at random in a 1:1 ratio. The primary endpoint was overall survival (OS) and secondary end points included time to progression (TTP), objective response rate, and safety.Total 148 patients were randomly assigned to the GV1001 (n = 75) and control groups (n = 73). The GV1001 group showed improved median OS (11.3 vs. 7.5 months, P = 0.021) and TTP (7.3 vs. 4.5 months, P = 0.021) compared to the control group. Grade >3 adverse events were reported in 77.3% and 73.1% in the GV1001 and control groups (P = 0.562), respectively.GV1001 plus gemcitabine/capecitabine improved OS and TTP compared to gemcitabine/capecitabine alone in eotaxin-high patients with advanced PDAC.NCT02854072.© 2023. The Author(s).