hypopharyngeal cancer
Conditions
Interventions
experimental group:Tislelizumab + cetuximab beta+ TP (docetaxel + cisplatin)
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Voluntary signing of written informed consent before screening; 2) Age 18-70 years old; 3) ECOG performance status score 0-1; 4) Histologically or pathologically confirmed hypopharyngeal squamous cell carcinoma; 5) Initial treatment of locally advanced hypopharyngeal carcinoma (stage III-IVB, AJCC 8th edition); 6) According to the solid tumor response evaluation criteria (RECIST version 1.1), there are evaluable lesions; 7) Adequate organ function, defined as the following laboratory test results =14 days before treatment (patients must not have received blood transfusions or growth factor support due to neutrophil counts, platelets or hemoglobin below the study requirements within 14 days before blood sampling): (a) Patients must meet the following laboratory test results: absolute neutrophil count = 1.5×10^9/L, platelets = 100×10^9/L, hemoglobin = 90g/L; (b) Renal function requirements within 4 weeks before treatment: endogenous creatinine clearance = 60mL/min. (calculated based on 24-hour urine creatinine or Cockcroft-Gault formula); (c) serum total bilirubin = 1.5 times the upper limit of normal range (ULN) (Gilbert syndrome patients can be included if their total bilirubin is = 3 times ULN); (d) AST and ALT = 3 times ULN. If the patient has liver metastasis, the standard is AST and ALT = 5 times ULN; 8) Patients with hepatitis B virus (HBV) infection and inactive/asymptomatic HBV carriers, or patients with chronic or active HBV; patients with HBV DNA = 2000 copies/mL at screening will be allowed to be included; patients with positive hepatitis C antibodies will be allowed to be included if HCV-RNA is negative at screening; 9) Women of childbearing age (WOCBP) must be willing to take highly effective contraceptive measures during the study and for = 60 days after the last dose of study treatment (including chemotherapy), and = Negative urine or serum pregnancy test results within 7 days; Women of childbearing age are defined as any woman who has had menarche and has not undergone sterilization surgery (hysterectomy or bilateral oophorectomy) and has not yet reached menopause; Menopause is defined as women aged > 45 years who have been amenorrhea for 12 months without other biological or physiological reasons; In addition, to confirm menopause, the serum follicle-stimulating hormone (FSH) level of women under the age of 55 must be > 40mIU/mL; 10) Male subjects who have not been sterilized must be willing to take highly effective contraceptive measures during the study and for = 60 days after the last dose of study treatment (including chemotherapy)
Exclusion criteria
Exclusion criteria: 1) Patients who have received any treatment for hypopharyngeal squamous cell carcinoma in the past; 2) Patients with evidence of fistula (esophageal/bronchial or esophageal/aorta); 3) Evidence of esophageal obstruction that is not suitable for treatment; 4) Patients who have received treatment targeting PD-1, PD-L1, PD-L2, or CTLA4; 5) Patients with active autoimmune diseases or a history of autoimmune diseases that may relapse (patients with the following diseases are not excluded and can enter further screening: (1) Controllable type 1 diabetes; (2) Hypothyroidism (if it can be controlled with hormone replacement therapy alone); (3) Controllable celiac disease; (4) Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia); (5) Any other disease that is not expected to relapse if there are no external triggers); 6) Before treatment = Any active malignancy within 2 years, excluding the specific cancer being studied in this study and locally recurrent cancer that has been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ or breast cancer); 7) Any condition requiring systemic treatment with corticosteroids (prednisone at a dose greater than 10 mg/day or equivalent) or other immunosuppressive agents within 14 days before treatment; patients who are currently or have previously used any of the following steroid regimens can be included: (a) Adrenaline replacement steroids (prednisone =10mg/day or equivalent dose of similar drugs); (b) topical, ophthalmic, intra-articular, intranasal and inhaled corticosteroids with minimal systemic absorption; (c) short-term (=7 days) use of corticosteroids for prevention (e.g., to prevent contrast agent allergy) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reactions caused by contact allergens); 8) history of interstitial lung disease, non-infectious pneumonia or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc.; 9) severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral treatment within 14 days before treatment; 10) known history of HIV infection; 11) any major surgery requiring general anesthesia within =28 days before treatment; 12) previous allogeneic stem cell transplantation or organ transplantation; 13) any of the following cardiovascular risk factors: (a) = Cardiac chest pain within 28 days, defined as moderate pain that limits instrumental activities of daily life; (b) symptomatic pulmonary embolism within 28 days before treatment; (c) acute myocardial infarction within 6 months before treatment; (d) any history of heart failure reaching New York Heart Association class III or IV within 6 months before treatment; (e) ventricular arrhythmia of = grade 2 within 6 months before treatment; (f) cerebrovascular accident within 6 months before treatment; (g) uncontrolled hypertension: systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg despite the use of antihypertensive drugs within 28 days before treatment or before the first dose of study drug (h) before treatment = 28 days of any syncope or convulsion; 14) History of severe hypersensitivity to other monoclonal antibodies; 15) Received Chinese herbal medicine or Chinese patent medicine for cancer control within 14 days before the first dose of the study drug; 16) Received live vaccine inject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactShichuan Zhang
Sichuan Cancer Hospital
Outcome results
None listed