Neoadjuvant IBI110 and Sintilimab in Combination with Chemotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)- a Phase Ib Clinical Trial
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).
• Signed informed consent and willing to complete the study as per the protocol;
• Age ≥ 18 years and ≤ 75 years;
• Histologically confirmed head and neck squamous cell carcinoma, including primary sites in the oropharynx, oral cavity, larynx, and hypopharynx;
• Resectable locally advanced head and neck squamous cell carcinoma (AJCC 8th edition: Stage III-IVB);
• At least one measurable lesion before treatment, meeting the RECIST 1.1 criteria for measurable disease;
• Expected survival \> 3 months;
• ECOG performance status 0-1;
• Adequate organ function meeting the following criteria:
∙ Absolute neutrophil count (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, see Appendix III);
‣ Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulants such as low-molecular-weight heparin or warfarin with INR within the therapeutic range may be screened);
• Patients with HBV infection and inactive/asymptomatic HBV carriers, or those with chronic or active HBV, may be enrolled if HBV DNA \< 500 IU/mL (or 2500 copies/mL) at screening. Patients with positive HCV antibodies may be enrolled if HCV-RNA is negative at screening;
⁃ Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before treatment and use medically accepted contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 3 months after the last dose of sintilimab and 6 months after the last dose of chemotherapy;
⁃ Non-sterilized male participants must agree to use medically accepted contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 3 months after the last dose of toripalimab and 6 months after the last dose of chemotherapy.