drugset / Trial / NCT05862168

Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective, Phase II Trial

NCT05862168 ↗

Phase 2 Recruiting 30 enrolled Weijia Fang, MD
NaSingle-groupOpen-labelTreatment

Summary

TPF is still recommended as the preferred induction chemotherapy regimen for nonsurgical treatment of patients with LA HNSCC. Based on the KEYNOTE-048 study, all major guidelines recommend PD-1 monotherapy or PD-1 combined with chemotherapy as the new first-line standard treatment for patients with advanced HNSCC. The immunotherapy in operable LA HNSCC was also explored as neoadjuvant therapy due to the excellent data in advanced HNSCC. These explorations have also achieved good results. Therefore, this study aims to explore the pathological remission rate, the long-term benefit and safety of Tislelizumab combined with albumin paclitaxel, cisplatin and fluorouracil for locally advanced oral squamous cell carcinoma.

Timeline

Start
2023-05-08
Primary completion
2024-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Albumin paclitaxel Unknown 200 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 20 mg/m2 Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Subject fluorouracil Small molecule 600 mg/m2 Intravenous