head and neck squamous cell carcinoma
Conditions
Interventions
experimental group:anti PD-1 monoclonal antibody, platinum based chemotherapy, oral fluorouracil
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Potential resectable head and neck squamous cell carcinoma confirmed by histopathology or cytology (excluding neuroendocrine tumor and other pathological types); 2.Identified as potential resectable HNSCC by Otolaryngology Department and received neoadjuvant therapy to achieve the goal of down-stage or tumor shrinkage; 3.Have not received Chemotherapy and immunotherapy for head and neck squamous cell carcinoma before. (mainly including chemotherapy and anti-CTLA-4, PD-1 / PD-L1 monoclonal antibody immunotherapy); 4.According to the imRECIST criteria, have at least one measurable target lesion to be evaluated; 5.Have signed written informed consent, and be able to comply with the follow-up procedures specified in the protocol; 6.Aged 18 to 75 years; 7.Expected survival time longer than 12 weeks; 8.Female of childbearing age or male with female sexual partner of childbearing age should take effective contraceptive measures until 6 months after the treatment period; 9.Have sufficient organ and bone marrow function, which is defined as follows: (1)Blood routine: absolute neutrophil count (ANC) >= 1.5x10^9 / L; platelet count (PLT) >= 80x 10^9 / L; hemoglobin content (Hgb)>=9.0 g / dl; (2)Liver function: serum total bilirubin (TBIL)= 28 g / L; (3)Renal function: serum creatinine (CR)=40 ml / min (calculated by Cockcroft / Gault formula): Female: CrCl = [(140-age) x body weight (kg) x 0.85]/[72 x serum creatinine ](mg / dl); Male: CrCl = [(140-age) x body weight (kg) x 1.00]/[72 x serum creatinine] (mg / dl). (4)Patients without anticoagulant therapy: INR or APTT=2 +, 24-hour urine should be collected, and the urine protein content should be less than 1.0g/24 hours. 10.Patient shoule participate voluntarily, be fully informed consent,sign written informed consent, and have good compliance.
Exclusion criteria
Exclusion criteria: 1.Previous systemic chemotherapy based on fluorouracil or platinum (except for low-dose radiosensitizer) has been used; 2.Previously received local radiotherapy; 3.Patients with distant metastasis or other unresectable head and neck squamous cell carcinoma; 4.Active immunodeficiency or autoimmune disease requiring systemic treatment (including corticosteroids and immunosuppressants) occurred within 2 years before randomization. Replacement therapy is not considered as systemic therapy, and the following patients can be selected: Patients with autoimmune hypothyroidism who have received thyroid hormone replacement therapy; Type II diabetes that can be controlled by insulin therapy; 5.Central nervous system metastasis (MRI scan is needed to exclude if suspected); 6.Participate in another intervention clinical study at the same time, unless participating in an observational (non intervention) clinical study or in the follow-up stage of an intervention study; 7.History of severe cardiovascular and cerebrovascular diseases: (1)History of heart disease, myocardial infarction, or cerebrovascular accident with NYHA cardiac function grade II or more in 3 months before randomization; (2)Left ventricular ejection fraction (LVEF) was less than 50% by echocardiography; (3)Poor control of arrhythmias, or unstable angina; (4)The corrected QT interval was more than 500 ms (calculated by fridericia method). Hypertension (systolic blood pressure >= 150mmhg and / or diastolic blood pressure >= 100mmhg) that is difficult to control by drugs (based on the average of >= 3 blood pressure readings obtained from >= 2 measurements); (5)Hypertensive crisis or hypertensive encephalopathy occurred in the past. 8.The presence of more than a small amount of pericardial effusion, uncontrolled pleural effusion or clinically significant peritoneal effusion during screening is defined as meeting the following criteria: pleural effusion and peritoneal effusion can be detected by physical examination during screening, or pleural effusion and peritoneal effusion need to be punctured during screening; 9.Any severe acute or chronic infection requiring systemic antimicrobial, antifungal or antiviral treatment (e.g., tuberculosis) is screened, excluding viral hepatitis; 10.History of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding within 6 months before randomization, including severe esophageal and gastric varices with high risk of bleeding, local active ulcer lesions and persistent positive fecal occult blood; 11.Live attenuated vaccine was vaccinated within 4 weeks before randomization, or it is planned to be vaccinated during anti-PD-1 monoclonal antibody treatment or within 5 months after the last administration; 12.Received systemic immunostimulants (including interferon and IL-2) within 4 weeks or 5 drug half lives before randomization, whichever is longer. Received systemic immunosuppressive drugs (such as glucocorticoids) within 2 weeks, or expected to use systemic immunosuppressive drugs during the study. The exceptions are as follows: (1)Treated with acute, low-dose systemic immunosuppressive drugs or single dose systemic immunosuppressive drugs (such as glucocorticoid administration for 48 hours to prevent and treat contrast agent allergy); (2)For the treatment of chronic obstructive pulmonary disease (COPD) or bronchial asthma, only local (such as external use of skin, inhalation, etc.) and physiological dose of systemi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main Pathological Remission Rate;Disease Control Rate;Quality of life;Incidence of Severe Adverse Effect;To evaluate the safety and tolerability of chemotherapy combined with anti-PD-1 mab; | — |
Countries
China
Contacts
Public ContactZhao Mingfang
The First Affiliated Hospital of China Medical University
Outcome results
None listed