Table 1.
Immunotherapy combined with neoadjuvant chemoradiotherapy for resectable esophageal squamous cell carcinoma: ongoing trials.
| Registration | Phase | Study Cohort | Control Cohort | Primary Endpoints |
Secondary Endpoints |
|---|---|---|---|---|---|
|
NCT04435197 (PALACE-2) |
II | Pembrolizumab + CRT (Paclitaxel + Carboplatin) | pCR | DFS, OS | |
| NCT04437212 | II | Toripalimab + CRT (Paclitaxel + Cisplatin) |
MPR | DFS, OS, AEs | |
| NCT03044613 | Ib | Nivolumab + CRT (Paclitaxel + Carboplatin) |
Nivolumab + Relatlimab + CRT (Paclitaxel + Carboplatin) | AEs | pCR, OS, RFS |
|
NCT03064490 (PROCEED) |
II | Pembrolizumab + CRT (Paclitaxel + Carboplatin) | pCR | AEs | |
| NCT04006041 | II | Toripalimab + CRT (Paclitaxel + Cisplatin) |
pCR | OS, DFS, AEs, R0 resection rate | |
| NCT04177875 | II | Toripalimab + CRT (Docetaxel + Nab-paclitaxel + Cisplatin) | MPR, ORR | DFS, OS, AEs | |
| NCT04229459 | II | Nivolumab + Cetuximab + CRT (Cisplatin + 5-FU) | pCR, PFS, AEs | OS | |
| NCT04568200 | II | Durvalumab + CRT (Paclitaxel + Carboplatin) |
Placebo + CRT (Paclitaxel + Carboplatin) | Tumor response, pathological response | R0 resection rate, AEs, PFS, OS |
| NCT04644250 | II | Toripalimab + CRT (Paclitaxel liposome + Carboplatin) | pCR | AEs, OS, DFS, MPR, ORR, R0 resection rate | |
| NCT04776590 | II | Tislelizumab + CRT (Nab-paclitaxel + Carboplatin) | pCR | DFS, OS | |
| NCT04888403 | II | Toripalimab + CRT (Nab-paclitaxel + Nedaplatin) | pCR | MPR, DFS, R0 resection rate | |
| NCT04929392 | II | Pembrolizumab + Lenvatinib + CRT (Nab-paclitaxel + Carboplatin) | pCR, cCR | AEs, DFS, OS | |
| NCT04974047 | II | Tislelizumab + CT (Paclitaxel + Cisplatin) |
Tislelizumab + CRT (Paclitaxel + Cisplatin/5-FU + Cisplatin) | pCR | MPR, R0 resection rate, DFS, EFS, ORR, AEs |
| NCT03165994 | II | Sotigalimab + CRT (Paclitaxel + Carboplatin) |
pCR | R0 resection rate, pathologic stage, radiographic/metabolic response, AEs | |
| NCT03490292 | I/II | Avelumab +CRT (Paclitaxel + Carboplatin) |
DLT, pCR | AEs, DFS, R0 resection rate | |
| NCT03857763 | II | Apatinib + CRT (Paclitaxel + Cisplatin) |
pCR | R0 resection rate, DFS, OS, AEs | |
| NCT04426955 | III | Camrelizumab + CRT (Paclitaxel + Cisplatin) | Placebo + CRT (Paclitaxel + Cisplatin) | PFS | OS, ORR, DoR, AEs |
CRT, chemoradiotherapy; pCR, pathological complete response; DFS, disease-free survival; OS, overall survival; MPR, major pathologic response; AEs, adverse events; RFS, recurrence-free survival; ORR, objective response rate; PFS, progression-free survival; cCR, clinical complete response; EFS, event-free survival; CT, chemotherapy; DLT, dose-limiting toxicity; DoR, duration of response.