Squamous cell carcinoma of the head and neck, HNSCC
Conditions
Interventions
Observation group:None
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age greater than 18 years old (2) Clinical cell carcinoma of the head and neck confirmed by pathological tissues (3) Have not undergone surgical treatment for this tumor before (4) ECOG score 0-1 (5) No contraindications to chemotherapy, immunotherapy and radiotherapy (6) The functional level of major organs meets the following criteria: 1) The criteria for routine blood examination should meet: WBC>=3.0×10^9/L, ANC>=2.0×10^9/L, PLT>=100×10^9/L, HGB>=90g/L (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors); 2) Biochemical examination should meet the following standards: TBIL = 60ml/min (Cockcroft-Gault formula); 3) Good coagulation function: defined as the international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; 4) cardiac enzyme spectrum within the normal range; (7) Women of childbearing potential must have taken reliable contraceptive measures, or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result, and be willing to use an effective method of contraception during the trial. For male subjects whose partner is a woman of childbearing age, an effective method of contraception should be used for the duration of the trial.
Exclusion criteria
Exclusion criteria: (1) Previous or concurrent suffering from other uncured malignant tumors, except for cured head and neck squamous cell carcinoma (2) Have any active autoimmune disease or have a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement therapy can be included after normal)); Patients with vitiligo or who have had complete remission of asthma in childhood and do not require any intervention in adulthood may be included, but asthma patients requiring medical intervention with bronchodilators are not included; (3) Patients with uncontrolled cardiovascular disease grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >=470ms): According to NYHA standards, grade III ~ IV cardiac insufficiency or cardiac color ultrasound showed left ventricular ejection fraction (LVEF) =104 copies/ml) or hepatitis C (hepatitis C antibody positive. and HCR-RNA is higher than the lower limit of detection of the analytical method); (5) Unable to collect throat swabs or diagnosed by a doctor as not suitable for radiotherapy (6) Within 4 weeks before the first radiotherapy (subjects who have entered the follow-up period are counted as the time of the last use of the investigational drug or device) or are participating in other clinical studies; (7) Pregnant or lactating women (8) In the judgment of the investigator, the subject has other factors that may lead to the termination of the study, such as other serious diseases (including mental illnesses) requiring concurrent treatment, serious abnormalities in laboratory test values, family or social factors, which may affect the safety of the subjects or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) was evaluated according to RECISTv1.1 criteria.;Security;The degree of tumor recession during radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactQiao Qiao
The First Affiliated Hospital of China Medical University
Outcome results
None listed