OncoMatch/Clinical Trials/NCT06494943
Induction IBI110 and Sintilimab with Chemotherapy in LA HNSCC
Is NCT06494943 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage III, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06494943 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug, systemic corticosteroids or other immunosuppressive drugs, anti-tumor vaccination or live vaccination disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or IVB is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages