drugset / Trial / NCT06426797
Neoadjuvant Cadonilimab Combined With Anlotinib in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Phase 2
Not yet recruiting
25 enrolled
Peking University People's Hospital
Akeso Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to learn if cadonilimab combined with anlotinib can be a safe and effective neoadjuvant therapy in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). The main questions it aims to answer are: What level of pathological complete response (pCR) rate can be achieved with this neoadjuvant regimen? Is this neoadjuvant regimen safe enough with acceptable toxicity? Participants will: Receive cadonilimab (10mg/Kg, ivgtt, d1) and anlotinib (12mg, P.O., d1-d14) on a 21-day regimen for 3 cycles. Undertake radical resection of ESCC after neoadjuvant therapy if there is no surgical contraindication. Accept an follow-up for 2 years after surgery.
Timeline
- Start
- 2024-05
- Primary completion
- 2025-05
- Completion
- 2027-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cadonilimab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Catequentinib | Small molecule | 12 mg | Oral |