Clinical Trial

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

Recruiting Phase 2
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Record status
This record was last updated July 17, 2023 (before its estimated June 30, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-05-07.
Status change: Not Yet Recruiting → Recruiting 2023-07-14
Trial Details
NCT Number NCT05862168
Lead Sponsor Weijia Fang, MD
Conditions Oral Squamous Cell Carcinoma
Enrollment 30 participants
Start Date 2023-05-08
Primary Completion 2024-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2023-07-17