确定在标准治疗（FOLFOX 和贝伐珠单抗）中添加 durvalumab（抗 PD-L1）和 oleclumab（抗 CD73）是否可以增强转移性结直肠癌 (mCRC) 患者的抗肿瘤效果。 哥伦比亚-1 (NCT04068610) 是一项针对初治微卫星稳定 mCRC 患者的 Ib 期（可行性；第 1 部分）/II 期（随机；第 2 部分）试验。第 2 部分中的患者被随机分配接受标准治疗（对照组）或标准治疗加 durvalumab 和 oleclumab（实验组）。主要目标包括安全性和有效性。第 1 部分招募了 7 名患者，第 2 部分招募了 52 名患者（每组 n = 26 名患者）。第 2 部分的对照组和实验组中，≥3 级治疗相关不良事件 (TEAE) 的患者发生率分别为 80.8% 和 65.4%，其中 26.9% 和 46.3% 经历严重 TEAE。与对照组相比，实验组确认的客观缓解率 (ORR) 在数值上更高（61.5% [95% 置信区间 (CI), 40.6-79.8] vs 46.2% [95% CI, 26.6-66.6]），但FOLFOX 和贝伐珠单抗与 durvalumab 和 oleclumab 联合使用的安全性是可控的；然而，疗效结果并不保证在微卫星稳定 mCRC 患者中进一步开发这种组合。NCT04068610.© 2024。作者。

To determine whether the addition of durvalumab (anti-PD-L1) and oleclumab (anti-CD73) to standard-of-care treatment (FOLFOX and bevacizumab) enhances the anti-tumour effect in patients with metastatic colorectal cancer (mCRC).COLUMBIA-1 (NCT04068610) was a Phase Ib (feasibility; Part 1)/Phase II (randomised; Part 2) trial in patients with treatment-naïve microsatellite stable mCRC. Patients in Part 2 were randomised to receive standard-of-care (control arm) or standard-of-care plus durvalumab and oleclumab (experimental arm). Primary objectives included safety and efficacy.Seven patients were enrolled in Part 1 and 52 in Part 2 (n = 26 in each arm). Grade ≥3 treatment-emergent adverse events (TEAE) occurred in 80.8% and 65.4% of patients in the control and experimental arms of Part 2, respectively, with 26.9% and 46.3% experiencing serious TEAEs. The confirmed objective response rate (ORR) was numerically higher in the experimental arm compared with the control arm (61.5% [95% confidence interval (CI), 40.6-79.8] vs 46.2% [95% CI, 26.6-66.6]) but did not meet the statistically significant threshold in either arm.The safety profile of FOLFOX and bevacizumab in combination with durvalumab and oleclumab was manageable; however, the efficacy results do not warrant further development of this combination in patients with microsatellite stable mCRC.NCT04068610.© 2024. The Author(s).