Locally advanced head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Toripalimab +Docetaxel + Cisplatin + Fluorouracil
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically/cytology confirmed the initial treatment of LA-HNSCC (AJCC TNM staging 8th edition) clinical stage III-IV), the tumor can be evaluated and measured according to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) & irRECIST criteria, and informed consent of the patient is obtained ; 2. The tumor is located in: oral cavity (tongue, gum, floor of mouth, hard palate, buccal, retromolar area), oropharynx (HPV-), hypopharynx; 3. Aged 18 to 75 years, male or female; 4. Eastern Cooperative Oncology Group (ECOG) score of 0-1; 5. Exclude immune system-related diseases; 6. The general condition can tolerate the formulated treatment plan, liver and kidney function, three major routines, electrocardiogram and other tests exclude systemic chemotherapy contraindications (leukocytes >= 3.0x10^9/L, neutrophils >= 1.5x10^9/L, platelets >= 100x109/L , hemoglobin >= 5.5 mmol/L (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors); creatinine = 60ml /min (Cockcroft-Gault formula), AST <= 3 ULN, ALT <= 3 ULN, total bilirubin <= 1.5 ULN), myocardial enzymes within the normal range; Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the intended range of anticoagulant use; 7. Women of childbearing age must have taken reliable contraceptive measures, or a sexual pregnancy test within 7 days before treatment and the result is negative, male and female patients with fertility agree and guarantee that they will not become pregnant during the test and within 180 days after treatment; 8. Be able to obtain tumor pathological tissue samples before immunotherapy and postoperative tumor tissue samples to detect PD-L1, HPV/P16, immune cell infiltration, etc. before and after immunotherapy; 9. If the patient has not participated in other clinical research in the past 1 month, all subjects must sign the informed consent and indicate the date; 10. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with head and neck cancer whose histological or cytological diagnosis is non-squamous cell carcinoma, any patients with distant metastases or the pathological results of the patients are nasopharyngeal carcinoma, HPV+ oropharyngeal carcinoma, or laryngeal carcinoma; 2. Currently participating in and accepting other clinical studies, or no more than 1 month after accepting other clinical studies; 3. Those who have been vaccinated with live vaccines within 4 weeks before the first use of the study dose, are allowed to receive inactivated virus vaccines for seasonal influenza and injected drugs, but are not allowed to receive live attenuated influenza vaccines for nasal use; 4. Diagnosed with immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before taking the first study drug, with a history of allogeneic tissue/solid organ transplantation; 5. Past or concomitant other uncured malignant tumors or a history of other malignant tumor treatment, basal cell carcinoma of the skin or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or breast cancer that can be cured by local treatment except intraductal carcinoma in situ; 6. Anyone who is allergic to chemotherapy, macromolecular protein preparations or any anti-PD-1 antibody immunosuppressant; 7. Active autoimmune disease requiring systemic treatment or history of autoimmune disease (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjgren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis, hypothyroidism [after normal hormone replacement therapy] Included]), patients with vitiligo or who had complete remission of asthma in childhood and did not require any intervention in adulthood, but not patients with asthma requiring medical intervention with bronchodilators; or pre-existing PD-1/PD-L1/ History of PD-L2 immunosuppressive therapy, or confirmed human acquired immunodeficiency (HIV); 8. Active infection, including tuberculosis (clinical diagnosis includes clinical history, physical examination and imaging findings, and TB examination according to local medical routine), or known active hepatitis B (HBV-DNA >= 10^4 copies) number/ml) or positive for viral hepatitis C antibody, and HCR-RNA is higher than the detection limit of the analytical method); 9. If the subject has undergone major surgery, the toxicity and/or complications caused by the surgical intervention must be fully recovered before starting treatment; 10. Women of childbearing age who are pregnant or are expected to be pregnant or are breastfeeding cannot participate in the study; 11. Active infection or unexplained fever > 38.5 degree C during the screening period and before the first administration (subject to the investigator's judgment, the subjects with fever due to tumor can be enrolled); 12. Serious infection (NCI-CTCAE> grade 2) occurred within 28 days before the first study administration, such as severe pneumonia, bacteremia, infectious complications requiring hospitalization, or continuous use of antibiotics within 1 month before enrollment5 Days and above; 13. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia (ie, bronchiolitis obliterans
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response;Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate;Objective response rate;Disease control rate;Quality of life of patients;Overall survival;Progression free survival; | — |
Countries
China
Contacts
Public ContactLi Chao
Sichuan Cancer Hospital
Outcome results
None listed