drugset / Trial / NCT04473716
Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients
NaSequentialOpen-labelTreatment
Summary
The aim of this study is to use the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathological response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.
Timeline
- Start
- 2020-07-30
- Primary completion
- 2021-04-12
- Completion
- 2023-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |