OncoMatch/Clinical Trials/NCT05343325
The Efficacy and Safety of Neoadjuvant Low-dose Radiotherapy Combined With Chemoimmunotherapy in Locally Advanced HNSCC
Is NCT05343325 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab for head and neck squamous cell carcinoma.
Treatment: Tislelizumab — This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of neoadjuvant low-dose radiotherapy combined with chemoimmunotherapy in resectable locally advanced head and neck squamous cell carcinoma. The eligible patients are scheduled to administered neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin for two cycles. Radical resection will be performed in 3-4 weeks after two cycles of neoadjuvant therapy. The overall primary study hypothesis is that the novel neoadjuvant combination regime improves the pathological complete response (pCR) rate, with tolerable side effects.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage T3-4N0M0, T1-4N1-3M0, III-IVB (AJCC 8th edition)
staging T3-4N0M0 or T1-4N1-3M0, III-IVB, according to the eighth edition of the AJCC staging system
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any research drug
Any research drug received prior to the first dose of the current research drug
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 100 × 10^9/L
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN
Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test): Hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; and platelet count ≥ 100 × 10^9/L; Serum albumin ≥ 28 g/L; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min; Activated partial clotting enzyme time and international standardized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected treatment range of anticoagulants can be screened ). Thyroid Stimulating Hormone (TSH) ≤ULN; If abnormal, T3 and T4 levels should be examined, and patients with normal T3 and T4 levels can be screened.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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