head and neck squamous cell carcinoma
Conditions
Interventions
Treatment Group:1. Toripalimab was administered intravenously (no prophylaxis required) at a fixed dose of 240mg, 3mg/kg for subjects with body weight <50kg at baseline. Each infusion is 30 min (not l
2. Interferon alpha was injected subcutaneously at 300µg/ time every other day for a treatment cycle of 3 weeks.
Sponsors
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a) Age 18-75 years old, male or female; b) Patients with head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, and larynx) with a measurable lesion (spiral CT =10mm, meeting RECIST 1.1 criteria) confirmed by histopathology as recurrent/metastatic or locally advanced and inoperable after surgery; c) Tumor progression within 6 months after first-line treatment involving platinum-based chemotherapy; d) Tumor tissues for detection of PD-L1, RIG-I, and lncMX1-215 (paraffin specimens or fresh tumor tissues within 2 years) can be provided; e) ECOG score of 0 or 1; f) Expected survival =12 weeks; g) Major organ function is normal within 2 weeks prior to treatment, that is, the following criteria are met: • Bone marrow function: hemoglobin =100g/L, white cell count =4.0*10^9/L or neutrophil count =2.0*10^9/L, platelet count =100*10^9/L without blood transfusion or colony-stimulating factor support therapy; • Liver: serum total bilirubin level =1.5 times the normal upper limit, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =1.5 times the normal upper limit; • Kidney: blood creatinine level below 1.5 times the normal upper limit or creatinine clearance =60ml/min, urea nitrogen =200mg/L; • Urine protein 800ml by the surgical expert. • Heart function: no myocardial infarction within 1 year; Unstable angina pectoris; No symptomatic severe arrhythmia; Acardiac dysfunction; h) Women of childbearing age must have a negative serum pregnancy test result within 7 days before the first administration of the test drug; Fertile men or women with the possibility of becoming pregnant must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) throughout the trial and continue contraception for 3 months after the end of treatment; i) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up; j) Patients whom doctors believe will benefit from treatment.(YNMT)·
Exclusion criteria
Exclusion criteria: a) Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy; b) Patients who have previously received interferon alpha therapy; c) Patients currently receiving antitumor therapy; d) Major surgery had been performed or had not recovered from the side effects of surgery within 4 weeks prior to the first dose, radiotherapy, live vaccination, and immunotherapy within 2 weeks; e) Patients who have participated in or are participating in clinical trials of other drugs/therapies within 4 weeks prior to the first administration of the investigational drug. f) Received reradiotherapy to the head and neck area (including neck, supraclavicular, and subclavian lymph nodes) within 6 months before enrollment; g) tumors surrounding, invading or infiltrating large blood vessels, invading the skin or mucous cavity, or the tumor lesions appear ruptured bleeding; h) Active or uncontrollable metastatic central nervous system tumors diagnosed by imaging; i) a history of other malignancies within 5 years, with the exception of cured skin basal cell carcinoma, skin squamous cell carcinoma, early prostate cancer, and cervical carcinoma in situ; j) The patient has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators are not included); k) Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continue to use within 2 weeks prior to enrollment; l) Study patients who had received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to initial drug administration; m) Positive HIV antibody or treponema pallidum antibody test result; n) Patients with active hepatitis B or C: if HBsAg or HBcAb positive, add HBV DNA test (test results above the upper limit of the normal range); If the HCV antibody test is positive, add HCV RNA(the test result is higher than the upper limit of the normal range); o) those who are known to be allergic to interferon alpha products, recombinant humanized PD-1 monoclonal antibody drugs and their components; p) A large amount of pleural fluid or ascites accompanied by clinical symptoms requiring symptomatic management; q) a history of active lung disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or active pulmonary tuberculosis; r) Have any clinical problems that cannot be controlled, including but not limited to: persistent or active (serious) infection; Poorly controlled diabetes; Heart disease (Grade III/IV congestive heart failure or heart block as defined by the Heart Society of New York); Poorly controlled hypertension (persistent blood pressure greater than 150/90 MMHG); Deep vein thrombosis or pulmonary embolism occurred within 6 months before the first dose; Myocardial infarction; Severe or unstable arrhythmia or angina; Percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; Cerebrovascular accident, transient ischemic attack, cerebral embolism. s) Abnormal coagulation function (INR>2.0
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;overall survival;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| partial response;complete response;stable disease;progressive disease; | — |
Countries
China
Contacts
Public ContactJingzhou Hu
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed