Fluoropyrimidine-based combination chemotherapy plus targeted therapy is the standard initial treatment for unresectable metastatic colorectal cancer (mCRC), but the prognosis remains poor. This phase 3 trial (ClinicalTrials.gov: NCT03950154) assessed the efficacy and adverse events (AEs) of the combination of PD-1 blockade-activated DC-CIK (PD1-T) cells with XELOX plus bevacizumab as a first-line therapy in patients with mCRC. A total of 202 participants were enrolled and randomly assigned in a 1:1 ratio to receive either first-line XELOX plus bevacizumab (the control group, n = 102) or the same regimen plus autologous PD1-T cell immunotherapy (the immunotherapy group, n = 100) every 21 days for up to 6 cycles, followed by maintenance treatment with capecitabine and bevacizumab. The main endpoint of the trial was progression-free survival (PFS). The median follow-up was 19.5 months. Median PFS was 14.8 months (95% CI, 11.6–18.0) for the immunotherapy group compared with 9.9 months (8.0–11.8) for the control group (hazard ratio [HR], 0.60 [95% CI, 0.40–0.88]; p = 0.009). Median overall survival (OS) was not reached for the immunotherapy group and 25.6 months (95% CI, 18.3–32.8) for the control group (HR, 0.57 [95% CI, 0.33–0.98]; p = 0.043). Grade 3 or higher AEs occurred in 20.0% of patients in the immunotherapy group and 23.5% in the control groups, with no toxicity-associated deaths reported. The addition of PD1-T cells to first-line XELOX plus bevacizumab demonstrates significant clinical improvement of PFS and OS with well tolerability in patients with previously untreated mCRC.

以氟嘧啶为基础的联合化疗加靶向治疗是不可切除的转移性结直肠癌（mCRC）的标准初始治疗，但预后仍然较差。这项 3 期试验（ClinicalTrials.gov：NCT03950154）评估了 PD-1 阻断激活的 DC-CIK (PD1-T) 细胞与 XELOX 加贝伐单抗联合作为一线治疗的疗效和不良事件 (AE)。转移性结直肠癌患者。共有 202 名参与者入组，并以 1:1 的比例随机分配接受一线 XELOX 加贝伐单抗（对照组，n  = 102）或相同方案加自体 PD1-T 细胞免疫治疗（免疫治疗组，n  = 100) 每 21 天一次，最多 6 个周期，然后用卡培他滨和贝伐单抗维持治疗。该试验的主要终点是无进展生存期（PFS）。中位随访时间为 19.5 个月。免疫治疗组的中位 PFS 为 14.8 个月（95% CI，11.6–18.0），而对照组为 9.9 个月（8.0–11.8）（风险比 [HR]，0.60 [95% CI，0.40–0.88]；p  = 0.009）。免疫治疗组未达到中位总生存期 (OS)，对照组为 25.6 个月 (95% CI，18.3–32.8)（HR，0.57 [95% CI，0.33–0.98]；p  = 0.043）。免疫治疗组中 20.0% 的患者和对照组中 23.5% 的患者发生 3 级或以上 AE，没有报告与毒性相关的死亡。将 PD1-T 细胞添加到一线 XELOX 加贝伐珠单抗中表明，对于既往未经治疗的转移性结直肠癌患者，PFS 和 OS 具有显着的临床改善，并且具有良好的耐受性。