locally advanced hypopharyngeal carcinoma
Conditions
Interventions
experimental group:Tirelizumab combined with cisplatin and albumin-binding paclitaxel
Sponsors
Cancer Hospital Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before screening; 2. Aged 18-70 years; 3. ECOG physical status score 0-1; 4. Squamous cell carcinoma of the hypopharynx confirmed by histology or pathology; 5. T1N+M0, T2-4N0-3M0 (AJCC 8.0) at first diagnosis, according to AJCC 8th Edition; 6. The patient is suitable for and agrees to radical treatment; 7. According to the efficacy evaluation criteria for solid tumors (RECIST version 1.1), there were evaluable lesions; 8. Adequate organ function, defined as achievement of the following laboratory results = 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 90g/L; (2) Renal function requirements during the first 4 weeks of treatment: endogenous creatinine clearance >= 60mL/min (based on 24-hour creatinine or Cockcroft-Gault formula); (3) Serum total bilirubin = 60 days after the administration of the last study treatment, including chemotherapy, during the study period and 45 years of age for 12 months without other biological or physiological causes; In addition, to confirm menopause, serum follicle-stimulating hormone (FSH) levels must be greater than 40mIU/mL in women under 55 years of age. 11. Male patients who are not sterilized must be willing to use highly effective contraception for >= 60 days during the study period and after the last study treatment, including chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Previous treatment for hypopharyngeal squamous cell carcinoma; 2. Patients with evidence of fistula (esophagus/bronchus or esophagus/aorta); 3. Evidence of esophageal obstruction unsuitable for treatment; 4. Received PD-1, PD-L1, PD-L2, CTLA4 as the target of treatment; 5. Patients with active autoimmune disease or a history of autoimmune disease but likely to relapse (patients with the following diseases are not excluded and may be eligible for further screening: (1) Controllable type 1 diabetes; (2) Hypothyroidism (if controlled with hormone replacement therapy alone); (3) Controlled celiac disease; (4) Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, alopecia); (5) Any other disease that is not expected to recur without external triggers); 6. Any active malignant tumor within 2 years or less prior to treatment, the specific cancers being studied in this study and locally recurrent cancers that have been cured are excluded (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer or breast cancer in situ); 7. Any condition requiring systemic corticosteroid therapy (dose higher than 10mg/ day of prednisone or equivalent) or other immunosuppressant treatment within the period = grade 2 in the = 160mmHg or diastolic blood pressure >= 100mmHg despite the use of antihypertensive drugs within <= 28 days before treatment or the first administration of the study drug; (8) Had any episodes of syncope or convulsion within 28 days or less before treatment; 14. A history of severe hypersensitivity to other monoclonal antibodies; 15. Received a Chinese herbal or proprietary medicine f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (ORR) ;2-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response, pCR;disease control rate (DCR);2-year progression-free survival in patients with concurrent chemoradiotherapy; | — |
Countries
China
Contacts
Public ContactGui Lin
Cancer Hospital Chinese Academy of Medical Science
Outcome results
None listed