drugset / Trial / NCT05343325
The Efficacy and Safety of Neoadjuvant Low-dose Radiotherapy Combined With Chemoimmunotherapy in Locally Advanced HNSCC
Phase 2
Recruiting
25 enrolled
Fifth Affiliated Hospital, Sun Yat-Sen University
Dongguan People's Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of neoadjuvant low-dose radiotherapy combined with chemoimmunotherapy in resectable locally advanced head and neck squamous cell carcinoma. The eligible patients are scheduled to administered neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin for two cycles. Radical resection will be performed in 3-4 weeks after two cycles of neoadjuvant therapy. The overall primary study hypothesis is that the novel neoadjuvant combination regime improves the pathological complete response (pCR) rate, with tolerable side effects.
Timeline
- Start
- 2022-03-09
- Primary completion
- 2024-03-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 100 mg/m2 | — |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | — |