Radiotherapy Combined With PD-1 Inhibitor and GM-CSF for Advanced Recurrent Metastatic Head and Neck Tumors

Inclusion Criteria

• •1. Age ≥18 years old;
• •2. Patients with recurrent or metastatic advanced head and neck malignancies (including nasopharyngeal malignancies), with a clear pathological diagnosis, imaging diagnosis, and medical history, no clearly recommended standard treatment regimen or inability to tolerate standard treatment regimens, and clear measurable lesions (\>1 cm);
• •3. Patients with squamous cell carcinoma who progress after first-line antineoplastic therapy must include a platinum-containing combination chemotherapy or platinum-based concurrent chemoradiotherapy, and patients with secondary resistance after previous anti-PD-1/L1 therapy may also be enrolled;
• •4. There is no standard regimen recommended by guidelines after first-line treatment failure in patients with non-squamous cell carcinoma (eg, adenoid cystadenocarcinoma, lung metastases, sarcoma, etc.);
• •5. At least one lesion with a diameter of 1 cm to 5 cm (metastases ≥1 cm, if the patient has large metastases, partial tumor irradiation can be allowed) can be treated with radiation therapy at 16 to 24 Gy/2-3Fx doses; Lymph nodes can be used as stand-alone measurable lesions (if lymph nodes are evaluated as an evaluation lesion, they must meet the criteria for target lesions, see RECIST1.1 for definition of a lymph node target lesion);
• •6. Patients who have previously received radical radiotherapy need to have an interval of more than 6 months; Patients with an interval of more than 6 months from the previous radiotherapy;
• •7. In the past 6 months, there has been no acute coronary syndrome or malignant arrhythmia;
• •8. ECOG (Eastern Cooperative Oncology Group), score 0-2, life expectancy assessment ≥ 3 months;
• •9. There were no previous severe hematopoietic, cardiac, pulmonary, hepatic, or renal dysfunction or immunodeficiency;
• •10. Ejection fraction of cardiac color Doppler ultrasound ≥ 50%;
• •11. Myocardial enzyme profile and NT-proBNP do not exceed twice the upper limit of normal;
• •12. Troponin and CKMB values do not exceed twice the normal upper limit;
• •13. Patients who have had grade 2 or higher AV block in the past six months and need to consider pacemakers will not be included;
• •14. Blood pressure hypertension≤ 160mmHg and/or low pressure≤90mmHg. 1 week prior to enrollment, the level of organ function meets the following criteria:
• •Bone marrow function: hemoglobin ≥ 80g/L, white blood cell count ≥ 3.5\*10\^9/L or neutrophil count ≥1.5\*10\^9/L, platelet count ≥ 100\*10\^9/L, CD8+ T lymphocyte absolute value ≥200/μL; Liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, when the serum total bilirubin level \> 1.5 times the upper limit of normal, direct bilirubin level must ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal; (5.0 times ≤the upper limit of normal in patients with liver metastases); Kidney: serum creatinine level \< 1.5 times the upper limit of normal or creatinine clearance ≥ 50ml/min, urea nitrogen ≤ 200mg/L; serum albumin≥ 30g/L;
• •15. Patients must have the ability to understand and voluntarily sign informed consent forms.