OncoMatch/Clinical Trials/NCT05862168
Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective, Phase II Trial
Is NCT05862168 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tislelizumab and Albumin paclitaxel for oral squamous cell carcinoma.
Treatment: Tislelizumab · Albumin paclitaxel · Cisplatin · 5-Fluorouracil — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage III, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
No previous systematic therapy for OSCC (including chemotherapy, EGFR inhibitors, VEGFR inhibitors such as bevacizumab, immune checkpoint inhibition such as anti-PD-1 or PD-L1 antibodies, anti-ctLA-4 antibodies, etc.)
Cannot have received: radiation therapy
Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck
Cannot have received: chemotherapy
Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck
Cannot have received: surgery
Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck
Cannot have received: immunology-based treatment
Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck
Lab requirements
Blood counts
WBCs >3.0× 10^9/L, ANC >1.5× 10^9/L, platelets >75× 10^9/L, hemoglobin >9 g/L
Kidney function
Serum creatinine <1.5 times the upper limit of normal
Liver function
ALAT/ASAT <2.5 times the upper limit of normal and bilirubin <1.5 times the upper limit of normal
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
Adequte organ function based on laboratory test values obtained during the screening period：1）Blood routine: white blood cells (WBCs) >3.0× 109/L, ANC >1.5× 109/L, platelets >75× 109/L, hemoglobin >9 g/L, 2）Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) <2.5 times the upper limit of normal and bilirubin <1.5 times the upper limit of normal，3）Renal function: Serum creatinine <1.5 times the upper limit of normal，4）Coagulation function: INR, PT, APTT<1.5 times the upper limit of normal，5）Left ventricular ejection fraction (LVEF) ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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