Squamous cell carcinoma of the head and neck
Conditions
Interventions
Cohort 1: Adebrelimab + chemotherapy:Adebrelimab 1200mg IV q3w
nab-paclitaxel 130mg/m^2 IV on days 1&8
cisplatin 40mg/m2 IV on days 1&8
3-week cycle for 3 cycles
Cohort 2: Adebrelimab + Recatistimab + chemotherapy:Adebrelimab 1200mg IV q3w
Recatistimab 150mg SC q4w
nab-paclitaxel 130mg/m2 IV on days 1&8
cisplatin 40mg/m^2 IV on days 1&8
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (stage III-IV, T3-4N0-3M0), assessed by surgeon as potentially resectable; 2. No prior treatment for head and neck squamous cell carcinoma; 3. Presence of clinically evaluable lesion according to RECIST 1.1 at baseline; 4. Age >=18 years at signing of informed consent, both genders; 5. ECOG performance status 0-2; 6. Life expectancy >=6 months; 7. Adequate organ function (without blood components or growth factors within 14 days): WBC >=3.0×10?/L, ANC >=1.5×10?/L, PLT >=100×10?/L, Hb >=90 g/L; Serum creatinine =50 mL/min; Total bilirubin <=1.5×ULN, AST/ALT <=2.5×ULN; 8. Able and willing to comply with study and follow-up procedures; 9. Fertile males and females agree to use adequate contraception during the study and for 6 months after last dose; 10. Voluntarily joins the study, signs informed consent, good compliance, and able to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies or other immunotherapies; 2. Known allergy, hypersensitivity, or intolerance to study drugs or their analogs; 3. Participation in another antitumor drug trial within 4 weeks before first dose, or plan to receive live attenuated vaccine during the study; 4. Another malignancy within 5 years (except adequately treated cutaneous squamous cell or basal cell carcinoma); 5. Use of immunosuppressive drugs within 14 days before first dose of adebrelimab (excluding nasal spray, inhaled, or physiologic doses of systemic corticosteroids =450 ms in males, >=470 ms in females), NYHA class III-IV heart failure, LVEF 38.5°C during screening/before first dose; 9. History of drug abuse and unable to abstain, or mental disorders; 10. Major surgery within 4 weeks before first dose, or open wound or fracture; 11. HIV infection or known AIDS, active hepatitis B (HBV DNA >=500 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA above lower limit of detection), or co-infection; 12. Any other condition that the investigator deems unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Objective response rate;Pathological complete response rate;Event-free survival; | — |
Countries
China
Contacts
Public ContactZhao Jiandong
Chinese PLA General Hospital
Outcome results
None listed