Radiotherapy With Tislelizumab in Patients With Recurrent Head & Neck Cancer

Exclusion Criteria17

• Pregnant or breastfeeding, or planning to become pregnant during the study period
• The patient had another malignant tumor expcet HNSCC
• Have an active autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, test positive for HIV or have a history of any of these diseases, or have a history of organ transplantation;
• They had received reradiotherapy within 1 month prior to entering the study
• Receiving systemic immunosuppressive drugs within 2 weeks prior to commencing study treatment, or anticipating needing systemic immunosuppressive drugs during study treatment;
• having received systemic immune-stimulating agents (including but not limited to interferon or interleukin-2 \[IL-2\]) within 4 weeks prior to study treatment initiation or remaining within 5 half-lives (whichever is longer);
• A history of other malignancies within the past 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ;
• Severe cardiovascular disease (e.g., New York College of Cardiology heart disease class Ⅱ or greater, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months before commences study treatment;
• The subject has an active infection or infectious disease, or develops a fever of unknown origin (body temperature \>38.5 ° C) during screening and before the first dose;
• had received therapeutic oral or intravenous antibiotics within 2 weeks prior to starting the study; Patients receiving prophylactic antibiotic therapy, such as prevention of urinary tract infection or chronic obstructive pulmonary disease, were enrolled.
• Untreated active hepatitis (hepatitis B: HBsAg positive with abnormal liver function and HBV-DNA≥104ml; Hepatitis C: HCV-RNA≥103/ml or antiviral therapy required during the study);
• Immunotherapy such as PD-1/L1 antibody or CTLA-4 antibody within 4 weeks before enrollment.
• Chemotherapy or targeted therapy within 4 weeks prior to enrollment;
• Subjects have participated in or completed other clinical trials within 4 weeks prior to enrollment;
• Subjects may need to receive other antitumor treatments during the study;
• Subjects may need to have been vaccinated during the study or within 4 weeks prior to enrollment.
• A patient who, in the investigator's judgment, has other comorbidities that seriously jeopardize the patient's safety or interfere with the patient's completion of the study.