head and neck cancer
Conditions
Interventions
Experimental group:SBRT+PD-1 antibody
Sponsors
Shanghai Ninth People's Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Patients with recurrent or second primary HNSCC; 2.Patients without distant metastatisis; 3.ECOG PS <=2 ; 4.Without severe impairment of heart, live, kidney and marrow; 5.With estimated survival time of more than 6 months.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding, or planning to become pregnant during the study treatment or within 5 months after the last study treatment; 2. Suffering from active autoimmune disease or immunodeficiency disease, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, HIV test positive Or have a history of the above diseases, or have a history of organ transplantation; 3. Receive systemic immunosuppressive drug therapy (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-a [anti-tumor necrosis factor-a] within 2 weeks before starting study treatment. TNF-a] drugs), or the need for systemic immunosuppressive drug therapy during the expected study period; 4. Received systemic immunostimulant therapy (including but not limited to interferon or interleukin-2 [IL-2]) within 4 weeks before starting study treatment or within 5 drug half-lives (whichever is longer). ); 5. Those who have a history of severe allergic reactions to chimeric, humanized antibodies, or fusion proteins or are known to be allergic to the drug components of this study; 5. Those with a history of psychotropic drug abuse and unable to abstain or a history of mental disorders; 6. Patients with past and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc.; 7. History of other malignant tumors other than head and neck squamous cell carcinoma in the past 5 years, except for cured cervical carcinoma in situ, superficial bladder cancer, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ; 8. Severe cardiovascular disease (eg, New York Heart Association heart disease class II or above heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable within 3 months before starting study treatment angina pectoris; 9. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year progression free survival;Actue toxicity; | — |
Countries
China
Contacts
Public ContactZhu Guopei
Shanghai Ninth People's Hospital
Outcome results
None listed