Table 3.
Immunotherapy combined with radical chemoradiotherapy for unresectable esophageal squamous cell carcinoma: phase III ongoing trials.
| Registration | Phase | Population Studied |
Study Cohort | Control Cohort | Primary Endpoints | Secondary Endpoints |
|---|---|---|---|---|---|---|
|
NCT03957590 (RATIONALE-311) |
III | ESCC | Tislelizumab + CRT (Paclitaxel + Cisplatin) | Placebo + CRT (Paclitaxel + Cisplatin) | PFS | ORR, DoR, OS, AEs |
|
NCT04210115 (KEYNOTE-975) |
III | ESCC/EAC/GEJC | Pembrolizumab + CRT (Cisplatin + 5-FU or FOLFOX) | Placebo + CRT (Cisplatin + 5-FU or FOLFOX) | OS, EFS | AEs |
|
NCT04550260 (KUNLUN) |
III | ESCC | Durvalumab + CRT (Cisplatin + 5-FU or Cisplatin + Capecitabine) | Placebo + CRT (Cisplatin + 5-FU or Cisplatin + Capecitabine) | PFS | OS, AEs |
|
NCT04426955 (ESCORT-CRT) |
III | ESCC | Camrelizumab + CRT (Paclitaxel + Cisplatin) | Placebo + CRT (Paclitaxel + Cisplatin) | PFS | OS, ORR, DoR, AEs |
|
NCT04543617 (SKYSCRAPER-07) |
III | ESCC | CRT (Platinum-based) + Tiragolumab + Atezolizumab (Cohort A) CRT (Platinum-based) + Tiragolumab Placebo+ Atezolizumab (Cohort B) | CRT (Platinum-based) + Tiragolumab Placebo + Atezolizumab Placebo | PFS, OS | ORR, DoR, QoL, AEs |
CRT, chemoradiotherapy; ESCC, esophageal squamous cell carcinoma; EAC, esophageal adenocarcinoma; GEJC, gastroesophageal junction cancer; PFS, progression-free survival; ORR, objective response rate; DoR, duration of response; OS, overall survival; AEs, adverse events; EFS, event-free survival; QoL, quality of life.