drugset / Trial / NCT05357846
PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
Phase 3
Recruiting
422 enrolled
Sun Yat-sen University
Affiliated Cancer Hospital of Shantou University Medical College · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.
Timeline
- Start
- 2022-11-01
- Primary completion
- 2031-01-01
- Completion
- 2031-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 50 mg/m2 | Intravenous |