OncoMatch/Clinical Trials/NCT05758389
Tislelizumab Combined APF Chemotherapy in the Treatment of Locally Advanced Head and Neck Tumors
Is NCT05758389 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU for head and neck tumors.
Treatment: Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU — The goal of this clinical trial is to test in describe participant population. The main questions it aims to answer are: 1. evaluate the efficacy and safety of tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy in the treatment of locally advanced head and neck tumors. 2. the exploration of efficacy-related immune microenvironment genes Participants will receive tislelizumab combined with APF sequential surgery or radical concurrent chemoradiotherapy.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CDKN2A P16-negative (negative)
III-IVb (P16-)
Required: CDKN2A P16-positive (positive)
II-III (P16+)
Disease stage
Required: Stage III-IVB (P16-), II-III (P16+)
Excluded: Stage DISTANT METASTASIS
The clinical stage is III-IVb (P16-) or II-III (P16+); There is distant metastasis [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
Have not received radiotherapy and chemotherapy or other anti-tumor drugs before
Cannot have received: chemotherapy
Have not received radiotherapy and chemotherapy or other anti-tumor drugs before
Cannot have received: anti-tumor drugs
Have not received radiotherapy and chemotherapy or other anti-tumor drugs before
Cannot have received: immunotherapy
Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy Wait
Cannot have received: surgery
Received anti-tumor treatment in the past 6 months, including radiotherapy and chemotherapy, surgery, immunotherapy Wait
Lab requirements
Blood counts
Neutrophil count ≥ 1.5×10^9/L; Hemoglobin ≥ 10g/dL; Platelet count ≥ 100×10^9/L
Kidney function
Creatinine clearance ≥ 60ml/min
Liver function
Total bilirubin ≤1.5× ULN; AST and ALT < 1.5 ×ULN; Alkaline phosphatase ≤ 5× ULN
Cardiac function
No heart failure above NYHA grade II; LVEF ≥ 50%; no unstable angina; no myocardial infarction within 1 year; no clinically significant arrhythmias requiring intervention (including QTc interval ≥ 470 ms)
The following hematological indicators need to be met... The following biochemical indicators need to be met... heart failure above NYHA grade II or echocardiography showing left ventricular ejection fraction (LVEF) < 50%; unstable angina; myocardial infarction within 1 year; patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention (including QTc interval ≥ 470 ms)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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