Table 2.
Definitive concurrent chemoradiotherapy combined with immunotherapy for unresectable esophageal squamous cell carcinoma: phase III ongoing trials.
| Registration | Phase | Participants | Population | Study Cohort | Control Cohort | Primary Endpoints | Secondary Endpoints |
|---|---|---|---|---|---|---|---|
|
NCT03957590 RATIONALE311 |
III | 370 | Locally advanced ESCC | Tislelizumab + Chemotherapy (Paclitaxel + Cisplatin) + Radiotherapy(50.4Gy/28F) | Placebo + Chemotherapy (Paclitaxel + Cisplatin) + Radiotherapy(50.4GY/28F) | PFS | ORR, DoR, OS, AEs |
|
NCT04210115 KEYNOTE-975 |
III | 700 | TxN+M0,T2-T4aNxM0 ESCC/EAC/GEJC or TxN+M1(cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only) | Pembrolizumab + Chemotherapy (Cisplatin + 5-FU or FOLFOX) + Radiotherapy(50/25F or 60Gy/30F) | Placebo + Chemotherapy (Cisplatin + 5-FU or FOLFOX) + Radiotherapy(50/25F or 60GY/30F) | OS, EFS | AEs |
|
NCT04550260 KUNLUN |
III | 600 | Stage II-IVA ESCC | Durvalumab + Chemotherapy (Cisplatin + 5-FU or Cisplatin + Capecitabine) + Radiotherapy(50-64Gy) | Placebo + Chemotherapy (Cisplatin + 5-FU or Cisplatin + Capecitabine) + Radiotherapy(50-64GY) | PFS | OS, AEs |
|
NCT04426955 ESCORT-CRT |
III | 396 | Locally advanced ESCC | Camrelizumab + Chemotherapy (Paclitaxel + Cisplatin) + Radiotherapy(50.4Gy/28F) | Placebo + Chemotherapy (Paclitaxel + Cisplatin) + Radiotherapy(50.4GY/28F) | PFS | OS, ORR, DoR, AEs |
|
NCT04543617 SKYSCRAPER-07 |
III | 750 | Unresectable ESCC | Chemotherapy (Platinum-based) + Radiotherapy(standard care dose) + Tiragolumab + Atezolizumab (Cohort A) Chemotherapy (Platinum-based) + Radiotherapy(standard care dose) + Tiragolumab Placebo+ Atezolizumab (Cohort B) |
Chemotherapy (Platinum-based) + Radiotherapy(standard care dose) + Tiragolumab Placebo + Atezolizumab Placebo | PFS, OS | ORR, DoR, QoL, AEs |
| NCT04821778 | III | 2000 | Stage I-IVa ESCC/EAC(AJCC 8th) | Anti-PD-1/PD-L1 antibody + Chemotherapy (Paclitaxel/Platinum/5-FU) + Radiotherapy(50-66Gy/25-30F) | Chemotherapy (Paclitaxel/Platinum/5-FU) + Radiotherapy(50-66GY/25-30F) | OS | PFS, AE, LRFS, DMFS |
|
NCT04404491 ITCRTECR |
III | 240 | Stage II-IVA ESCC | Camrelizumab + Chemotherapy (Oxaliplatin +Capecitabine) + Radiotherapy(50-50.4Gy/25-28F) | Placebo + Chemotherapy (Oxaliplatin +Capecitabine) + Radiotherapy(50-50.4GY/25-28F) | AEs, PFS | ORR, OS |
| NCT05919030 | III | 155 | unresectable advanced, recurrent or metastatic ESCC(AJCC 8th) | Tislelizumab + Chemotherapy (Nab paclitaxel + Cisplatin)+Radiotherapy(39.6Gy/18F) | Tislelizumab + Chemotherapy (Nab paclitaxel + Cisplatin) | PFS | OS, ORR, DOR, AEs |
T, Tumor; N, regional lymph node; M, Metastasis; ESCC, esophageal squamous cell carcinoma; EAC, esophageal adenocarcinoma; GEJC, gastroesophageal junction cancer; AJCC, American Joint Committee on Cancer; 5-FU, 5-fluorouracil; FOLFOX, Leucovorin Calcium + Fluorouracil + Oxaliplatin; F, fraction; PFS, progression-free survival; DOR, duration of objective response; ORR, objective response rate; EFS, event-free survival; LRFS, locoregional recurrence free survival; OS, overall survival; AEs, adverse events; CCR, clinical complete response; PFS, progression-free survival; DMFS, distant metastasis free survival; QoL, quality of life.