drugset / Trial / NCT07645846
Neoadjuvant Docetaxel, Cisplatin, and Dual Immunotherapy for Sinonasal Carcinoma
Phase 2
Not yet recruiting
23 enrolled
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University · collabGuangdong Provincial People's Hospital · collabNanfang Hospital, Southern Medical University · collabQingyuan People's Hospital · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabZhujiang Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The main objective of this prospective study is to evaluate the effectiveness and safety of a novel neoadjuvant therapy for patients with locally advanced sinonasal carcinoma (SNC). The treatment consists of the standard TP chemotherapy regimen (docetaxel and cisplatin) combined with dual immunotherapy (sintilimab and ipilimumab N01) administered before surgery. Researchers aim to determine the major pathological response (MPR) rate and long-term survival outcomes, while also exploring if this combination treatment approach can help better preserve critical facial and organ functions for SNC patients.
Timeline
- Start
- 2026-07-31
- Primary completion
- 2028-08-01
- Completion
- 2030-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |