Clinical trials of ICIs in early-stage MSI colon and rectal cancer
| Studies | NCT | Drug (NA/A) | N | C/R | pCR (%) | Duration (w) | WW (%) | DFR (%)3-year | Ref. |
|---|---|---|---|---|---|---|---|---|---|
| Chalabi, 2020 | NCT03026140 | Nivolumab/ipilimumab (NA) | 20 | C | 60 | 6 | - | - | [17] |
| Chalabi, 2024 | NCT03026140 | Nivolumab/ipilimumab (NA) | 119 | C | 67 | 6 | - | 100 | [16] |
| de Gooyer, 2024 | NCT03026140 | Nivolumab/relatlimab (NA) | 59 | C | 67 | 6 | - | - | [23] |
| Hu, 2022 | NCT03926338 | Toripalimab +/– celecoxib (NA) | 34 | C | 88 vs 65 | 12 | - | - | [25] |
| Xu, 2024 | NCT05890742 | IBI301 + sintilimabvs sintilimab (NA) | 101 | C | 80 vs 47 | 6 | - | - | [22] |
| Shiu, 2024 | NCT05197322 | Pembrolizumab (NA) | 32 | C | 59 | 6 | - | - | [27] |
| Ludford, 2023 | NCT04082572 | Pembrolizumab (NA) | 27 | C | 66 | 24 | - | - | [28] |
| AZUR2, 2024 | NCT05855200 | Dostarlimab vs SOC (NA/A) | 711 | C | - | 12 | - | - | |
| Yu, 2024 | NCT04715633 | Camrelizumab + afatinib (NA) | 52 | C/R | 61 | 12–24 | 54 | - | [24] |
| de la Fouchardiere, 2024 | NCT04795661 | Pembrolizumab (NA/A) | 87 | C/R | 47 vs 68 | 3–6 | - | - | [26] |
| Cercek, 2022 | NCT04165772 | Dostarlimab (NA) | 41* | R | - | 24 | 100 | - | [29] |
| Chen, 2023 | NCT04304209 | Sintilimab +/– CHT (NA/A) | 17 | R | - | 12 | 53 | - | [31] |
| AZUR1, 2024 | NCT05723562 | Dostarlimab (NA) | 100 | R | - | 24 | - | - |
ICIs: immune checkpoint inhibitors; MSI: microsatellite unstable; nivolumab: anti-PD-1; ipilimumab: anti-CTLA4; relatlimab: anti-LAG3; toripalimab: anti-PD-1; celecoxib: COX2 inhibitor; pembrolizumab: anti-PD-1; camrelizumab: anti-PD-1; afatinib: VEGF inhibitor; IBI301: anti-CTLA4; sintilimab: anti-PD-1; dostarlimab: anti-PD-1. NCT: National Clinical Trial; NA: neoadjuvant; A: adjuvant; CHT: chemotherapy; pCR: pathological complete response; WW: watch and wait; DFS: disease-free survival; C/R: colon/rectum; SOC: standard of care; Ref.: reference. * Updated information