PD-1 Inhibitor Therapy Versus Radiotherapy in MPR Patients With Locally Advanced HNSCC After Neoadjuvant Immunochemotherapy (HNC-SYSU-006)

Exclusion Criteria

• •1 HNSCC is not the initial diagnosis of other malignant tumors or neoadjuvant therapy.
• •Prior to treatment An active autoimmune immune disease requiring systemic therapy (e.g. the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred in the last 2 years. Alternative therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;
• •Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• •Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
• •Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center);
• •Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
• •1\) HBV viral load \&lt before initial administration; At 1000 copies /ml (200 IU/ml), subjects should receive anti-HBV therapy to avoid viral reactivation throughout the study treatment period 2) For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required
• •Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the lower limit);
• •Pregnant or lactating women;
• •The presence of any serious or uncontrolled systemic disease, such as:
• •1. The resting electrocardiogram (ECG) presents significant and severely uncontrollable abnormalities in rhythm, conduction or morphology, such as complete left bundle branch block, Ⅱ degree or above heart block, ventricular arrhythmia or atrial fibrillation;
• •2. Unstable angina pectoris, congestive heart failure, and NYHA grade ≥ 2 chronic heart failure;
• •3. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment;
• •4. Poor blood pressure control (systolic \> 140 mmHg, diastolic \> 90 mmHg);
• •5. A history of non-infectious pneumonia requiring glucocorticoid therapy or clinically active interstitial lung disease within 1 year prior to initial administration;
• •6. Active pulmonary tuberculosis;
• •7. There is an active or uncontrolled infection that requires systemic treatment;
• •8. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
• •9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
• •10. Poor diabetes control (fasting blood glucose (FBG) \> 10mmol/L);
• •11. Urine routine indicated urine protein ≥++, and confirmed 24 hours urine protein quantity \> 1.0 g;
• •12. Patients with mental disorders and unable to cooperate with treatment;
• •Medical history or evidence of disease that may interfere with test results, prevent subjects from fully participating in the study, abnormal values of treatment or laboratory tests, or other conditions that the investigator considers unsuitable for enrollment. The investigator considers other potential risks unsuitable for participation in the study.