Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Cardonilizumab,10mg/Kg,D1,ivgtt
Albumin paclitaxel: 100mg/?, D1, D8, D15, ivgtt
Cisplatin: 25mg/?, D1, D8, D15, ivgtt
Radiotherapy, 1Gy/fraction, D1, D8, D15, Q3W, 3 cycles.
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)Untreated, pathologically confirmed stage III-IVB non-oropharyngeal head and neck squamous cell carcinoma and HPV negative oropharyngeal carcinoma, or HPV positive stage II-III oropharyngeal carcinoma (AJCC 8th); 2) Patients who have been assessed by surgeons as operable; 3) Patients aged 18-70 years; 4) Expected survival = 6 months; 5) ECOG: 0 ~ 1 score; 6) There are lesions that can be measured according to RECIST 1.1 criteria; 7) Major organ functions meet the following criteria (no blood components and cell growth factors are allowed within 14 days) : a) Hemoglobin HBG=90 g/L; Neutrophil ANC=1.5×10^9 /L; Platelet count PLT=100×10^9 /L; b) Serum albumin =28g/L; c) Total bilirubin TBIL=1.5×ULN (upper limit of normal), alanine aminotransferase ALT, aspartate aminotransferase AST=2.5×ULN; If there is liver metastasis, ALT and AST = 5 × ULN; d) Serum creatinine =1.5×ULN, and creatinine clearance =50 mL/min; e) Activated partial thromboplastin time (APTT) and international Normalized ratio (INR) =1.5×ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin, and INR can be screened within the intended therapeutic range of anticoagulants); f) Thyroid stimulating hormone TSH=ULN; If abnormal, T3 and T4 levels should be examined, and if T3 and T4 levels are normal, they can be selected. 8) Women of childbearing age should agree to use contraceptive methods (such as Iuds, contraceptives or condoms) during and for 3 months after the end of medication; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 3 months after the end of the study period; 9) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; 2) A history of allergy to any drug in Serplulimab, albumin-paclitaxel, or cisplatin; 3) A history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma; 4) Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 5) Have received any of the following treatments: a. Received any investigational drug prior to first use of the investigational drug; b. Enrolling in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; c. Subjects requiring systemic treatment with corticosteroids (equivalent dose greater than 10mg per day of prednisone) or other immunosuppressants within 2 weeks prior to initial use of the study drug, except for corticosteroids for local inflammation and prevention of allergy and nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroid and adrenal corticosteroid replacement at doses greater than 10mg daily prednisone therapeutic dose are permitted; d. Received an anti-tumor vaccine or a live vaccine within 4 weeks prior to the first administration of the investigational drug; e. Major surgery or severe injury within 4 weeks prior to the first use of the study drug; 6) Serious infections (CTCAE greater than grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; Baseline chest imaging findings indicate active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use); 7) Have active autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); However, it does not include patients with vitiligo or childhood asthma/allergies that have recovered and require no intervention as adults; 8) Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and bone marrow transplantation; 9) Patients found to have active pulmonary tuberculosis infection through medical history or CT examination, or had a history of active pulmonary tuberculosis infection within 1 year before enrollment, or had a history of active pulmonary tuberculosis infection 1 year before but had not received formal treatment; 10) Subjects had active hepatitis (HBV DNA=2000IU/ml or 10,000 copies/ml), hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of assay); 11) Known history of psychotropic substance abuse, alcohol abuse and drug use; 12) Those deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Objective remission rate;R0 removal rate;Rate of delayed surgery;3-year progression-free survival;3 years overall survival;Adverse reactions; | — |
Countries
China
Contacts
Public ContactZhigang Liu
Dongguan People's Hospital
Outcome results
None listed