head and neck squamous cell carcinoma
Conditions
Interventions
experiment group:Radiotherapy and medicine
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: >18 years old, both sexes; 2. Head and neck squamous cell carcinoma confirmed by pathology (histology or cytology), which cannot be cured by local treatment; 3. Locally advanced patients who are not suitable for surgery (referring to patients whose physical conditions are not allowed, who refuse surgery due to various reasons, or whose tumor burden is too large to be resected) and patients with recurrence and metastasis; 4. Unable to tolerate chemotherapy or refuse chemotherapy due to underlying diseases, such as GFR 2.5×10^9/L, platelet > 50×10^9/L, hemoglobin =6g/dL; Liver FUNCTION: TOTAL BILIRUBIN DOES NOT EXCEED 1.5 TIMES OF NORMAL UPPER LIMIT, GLUTAMIC-PYRUVIC TRANSAMINASE, GLUTAMIC-GRASS TRANSAMINASE DOES NOT EXCEED 2.5 TIMES OF NORMAL UPPER LIMIT, RENAL FUNCTION: CREATININE DOES NOT EXCEED 1.5 TIMES OF NORMAL UPPER LIMIT). 11. No congestive heart failure, unstable angina pectoris, or unstable arrhythmia occurred in the past 6 months. 12. No previous history of immune diseases.
Exclusion criteria
Exclusion criteria: 1, there is still any toxic reaction of CTCAE2 grade or above caused by previous anticancer treatment; 2, combined with obvious liver, kidney, heart, nerve, mental and other important organ diseases or dysfunction, If you have known poorly controlled diabetes, poorly controlled hypertension, liver failure, unstable angina pectoris, a history of myocardial infarction within 6 months, New York Heart Association class III or IV congestive heart failure, a history of cerebrovascular accident within 6 months, or a history of severe neurological or psychiatric illness; Patients with active severe clinical infection (CTCAE grade 3 or above); 3, had undergone major surgery (excluding previous diagnostic biopsy), radiation therapy, chemotherapy, treatment with monoclonal antibodies targeting epidermal growth factor receptor or signal transduction inhibitors, or immune checkpoint inhibitors within 4 weeks prior to trial entry; Has developed or currently has other malignant tumors within 4 or 5 years, except cured cervical carcinoma in situ, gastrointestinal intramucosal carcinoma, breast cancer and non-melanoma skin cancer, and superficial bladder tumor; 5. Active autoimmune diseases that may worsen upon receiving immune stimulants; 6, severe coagulation mechanism disorders, bleeding tendency; 7. Pregnant or lactating women, or those with pregnancy planning; 8. Active infections requiring systemic treatment, including active tuberculosis; 9. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 10. Current or recent (within 28 days before randomization) treatment with another trial drug or participation in another investigational trial; 11. Patients who were deemed ineligible for enrollment by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;1y-PFSR;1y-OSR;Duration of Response;Disease control rate; | — |
Countries
China
Contacts
Public ContactLi Dong, Yao Yuan
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed