drugset / Trial / NCT05125055
Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
RandomizedParallel-groupOpen-labelTreatment
Summary
To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.
Timeline
- Start
- 2021-10-01
- Primary completion
- 2024-09-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |
| Comparator | fluorouracil | Small molecule | 750 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |