drugset / Trial / NCT06356688
A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (Cadonilimab) in combination with platinum-containing chemotherapy (Paclitaxel Polymeric Micelles for Injection combined with Cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of Cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with Cadonilimab combined with chemotherapy.
Timeline
- Start
- 2025-04-20
- Primary completion
- 2027-06-01
- Completion
- 2027-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cadonilimab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 230 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |