drugset / Trial / NCT07584031
Adebrelimab Plus Full-course Neoadjuvant Therapy for Resectable Locally Advanced ESCC (Phase 2)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, single-center, randomized phase 2 study of adebrelimab plus full-course neoadjuvant therapy in resectable locally advanced esophageal squamous cell carcinoma. Patients achieving clinical complete response (cCR) after neoadjuvant treatment will be randomized 1:1 to watchful waiting with 2 cycles consolidation chemo-Immunotherapy or standard surgery. Primary endpoint is 2-year DFS. Secondary endpoints include OS, pCR/MPR, R0 resection rate, safety, and quality of life.
Timeline
- Start
- 2026-06-01
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adebrelimab | Monoclonal antibody | — | Intravenous |
| Subject | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |