Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective, Phase II Trial
Neoadjuvant Tislelizumab Combined With Albumin-paclitaxel, Cisplatin, and Fluorouracil in Patients With Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective,Phase II Study
Weijia Fang, MD
30 participants
May 8, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
The participants will receive 3 cycles of Tislelizumab, with 21 days each. 200mg of Tislelizumab will be used intravenously on the first day of each cycle.
The participants will receive 3 cycles of Albumin paclitaxel, with 21 days each. 200mg/m\^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.
The participants will receive 3 cycles of Cisplatin, with 21 days each. 20mg/m\^2 of Cisplatin will be used intravenously on days 1 through 3 of each cycle.
The participants will receive 3 cycles of 5-Fluorouracil, with 21 days each. 600mg/m\^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.
Locations(1)
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NCT05862168