drugset / Trial / NCT04473716

Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients

NCT04473716

Phase 1 Completed 20 enrolled Shanghai Jiao Tong University School of Medicine
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

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 260 mg/m2 Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous

Indications