XELOX（卡培他滨联合奥沙利铂）联合贝伐珠单抗（抗 VEGF-A 抗体）联合或不联合过继性细胞免疫治疗用于既往未治疗的转移性结直肠癌患者：一项多中心、开放标签、随机、对照、3 期试验

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.