Table 2.
Immunotherapy combined with neoadjuvant chemotherapy for resectable esophageal squamous cell carcinoma: ongoing trials.
| Registration | Phase | Study Cohort | Control Cohort | Primary Endpoints |
Secondary Endpoints |
|---|---|---|---|---|---|
|
NCT04280822 (HCHTOG1909) |
III | Toripalimab + CT (Paclitaxel + Cisplatin) | Placebo + CT (Paclitaxel + Cisplatin) |
EFS | pCR, DFS, OS, ORR, R0 resection rate, MPR, AEs, QoL |
| NCT04506138 | II | Camrelizumab + CT (Nab-paclitaxel + Carboplatin) | pCR, MPR | OS, EFS | |
| NCT04177797 | II | Toripalimab + CT (Paclitaxel + Carboplatin) | pCR | DCR, ORR, AEs | |
|
NCT03914443 (FRONTiER) |
I | Nivolumab + CT (5-FU + Cisplatin) (Cohort A/B) |
Nivolumab + CT (5-FU + Cisplatin + Docetaxel) (Cohort C/D) |
DLT | pCR, AEs, PFS, OS |
|
NCT04389177 (KEYSTONE-001) |
II | Pembrolizumab + CT (Paclitaxel + Carboplatin) | MPR | ORR, DFS, OS, R0 resection rate | |
|
NCT03437200 (CRUCIAL) |
II | Nivolumab + CT (FOLFOX) |
Nivolumab + Ipilimumab + CT (FOLFOX) | PFS | FFS, OS |
| NCT04460066 | Ib/II | ZKB001 + CT (Nab-paclitaxel + Cisplatin) |
Placebo + CT (Nab-paclitaxel + Cisplatin) |
MPR | R0 resection rate, pCR, DFS, EFS, OS, AEs |
| NCT04767295 | II | Camrelizumab + CT (Nab-paclitaxel + Carboplatin) |
pCR | OS, PFS, DCR, ORR | |
| NCT04804696 | II | Toripalimab + CT (Paclitaxel + Cisplatin) | pCR | ORR, R0 resection rate, MPR, DFS, OS, AEs | |
| NCT04848753 | III | Toripalimab + CT (Paclitaxel + Cisplatin) | Placebo + CT (Paclitaxel + Cisplatin) |
EFS | pCR, EFS, OS |
| NCT03917966 | II | Camrelizumab + CT (Docetaxel + Nedaplatin) | Camrelizumab + Apatinib | MPR | pCR, OS, DFS, LNR, R0 resection rate |
| NCT03946969 | II | Sintilimab + CT (Nab-paclitaxel + Cisplatin + S-1) | AEs | MPR, R0 resection rate, RFS, OS |
CT, chemotherapy; EFS, event-free survival; pCR, pathological complete response; DFS, disease-free survival; OS, overall survival; ORR, objective response rate; MPR, major pathologic response; AEs, adverse events; QoL, quality of life; DCR, disease control rate; DLT, dose-limiting toxicity; PFS, progression-free survival; FFS, failure-free survival; LNR, lymph node ratio; RFS, recurrence-free survival.