OncoMatch/Clinical Trials/NCT06494943
Induction IBI110 and Sintilimab with Chemotherapy in LA HNSCC
Is NCT06494943 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Sintilimab and IBI110 for head and neck cancer.
Treatment: Sintilimab · IBI110 · Paclitaxel · Cis Platinum — This study aims to investigate the efficacy and safety of combining sintilimab and the TP regimen with/without IBI110 for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
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: investigational drug
Any investigational drug within 4 weeks prior to the first use of the study drug
Cannot have received: systemic corticosteroids or other immunosuppressive drugs
Exception: corticosteroids used for local inflammation and prevention of allergies, nausea, and vomiting; inhaled or topical steroids and adrenal corticosteroid replacement therapy with doses >10 mg/day prednisone equivalent are allowed in the absence of active autoimmune disease
Systemic treatment with corticosteroids (daily dose >10 mg prednisone equivalent) or other immunosuppressive drugs within 2 weeks before the first use of the study drug
Cannot have received: anti-tumor vaccination or live vaccination
Exception: COVID-19 vaccination allowed if interval >2 weeks
Anti-tumor vaccination or live vaccination within 4 weeks prior to the first administration of the study drug (for COVID-19 vaccination, the interval between vaccination and treatment should be more than 2 weeks)
Cannot have received: major surgery or severe trauma
Major surgery or severe trauma within 4 weeks prior to the first use of the study drug
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL; Serum albumin ≥ 2.8 g/dL
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin ≤ 1.5 × ULN, ALT, AST, and/or ALP ≤ 3 × ULN
Adequate organ function meeting the following criteria: ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL; Serum albumin ≥ 2.8 g/dL; Total bilirubin ≤ 1.5 × ULN, ALT, AST, and/or ALP ≤ 3 × ULN; Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 mL/min (Cockcroft-Gault); APTT and INR ≤ 1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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