head and neck squamous cell carcinoma
Conditions
Interventions
treatment group:Toripalimab
Sponsors
the First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) 18-70 years old; (2) Postoperative head and neck squamous cell carcinoma conforms to any of the following criteria: 1) Lymph node rupture and metastasis; 2) More than 6 lymphatic metastases; 3) Positive cutting edge; 4) Postoperative blood ctDNA+ (for patients with stage T3/T4N+ undergoing postoperative blood ctDNA testing, if positive, can be included); (3) Squamous cell carcinoma confirmed by pathological tissue; (4) ECOG score 0-1; (5) Have not received any immunotherapy or biotherapy anti-tumor therapy in the past; (6) No contraindications of chemotherapy, immunotherapy or radiotherapy; (7) The functional level of major organs meets the following standards: 1) Blood routine examination standards should meet: WBC=3.0×109/L, ANC=2.0×109/L, PLT=100×109/L, HGB=90g/L (no blood transfusion and blood products within 14 days, no G-CSF or other hematopoietic stimulation factors correction) 2) Biochemical tests should meet the following criteria: TBIL=2.0×ULN, ALT, AST=2.5×ULN, BUN and CRE=1.5×ULN or endogenous creatinine clearance = 60mL /min (Cockcroft-Gault formula); 3) Good coagulation function: defined as international standardized ratio (INR) or prothrombin time (PT) =1.5 TIMES ULN; If the subject is receiving anticoagulant therapy, as long as PT is within the prescribed range of anticoagulant drugs; 4) The myocardial enzyme profile was within the normal range; (8) Women of childbearing age must have taken a reliable contraceptive method or had a pregnancy test (serum or urine) within 7 days prior to enrollment with negative results and be willing to use an effective method of contraception during the trial and within 2 months after the last anti-PD-1 antibody was given. For male subjects whose partner is a woman of reproductive age, effective contraception should be used during the trial period and within 2 months after the last anti-PD-1 antibody is given.
Exclusion criteria
Exclusion criteria: (1) have a prior or concurrent uncured malignancy, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer; (2) have any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (included after normal hormone replacement therapy); Patients with vitiligo or asthma in complete remission in childhood and without any intervention as adults were eligible for inclusion, while those requiring medical intervention with bronchodilators were not. (3) uncontrolled cardiovascular diseases: grade ? or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval =470 ms); Patients with grade ? ~ ? cardiac insufficiency according to NYHA standard, or left ventricular ejection fraction (LVEF) 38.5? during the screening period and before the first drug administration (according to the judgment of the investigator, the subjects' fever caused by tumor can be included in the study); (5) patients with congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA=104 copy number /ml) or hepatitis C (positive hepatitis C antibody, and HCR-RNA higher than the detection limit of analysis method); (6) Previous immunotherapy against PD-1/PD-L1; (7) Known allergy to cisplatin, macromolecular protein preparations, or to any anti-PD-1 antibody component; (8) If the subject has undergone major surgery, the resulting toxic effects and/or complications must be fully recovered; (9) Within 4 weeks before the first use of the study drug (the time of the last use of the experimental drug or device for subjects who have entered the follow-up period) or are participating in other clinical studies; (10) Those who received live vaccine within 4 weeks prior to the initial use of the study are permitted to receive injectable inactivated virus vaccine for seasonal influenza, but are not permitted to receive intranasal attenuated live influenza vaccine; (11) women who are pregnant or breastfeeding; (12) According to the investigator's judgment, subjects have other factors that may cause them to be forced to terminate the study, such as other serious diseases (including mental illness) requiring combined treatment, seriously abnormal laboratory test values, family or social factors, which may affect the safety of subjects or the collection of test data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactQiao Qiao
the first hospital of China Medical University
Outcome results
None listed