Head and neck squamous cell carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent; 2: Age >= 18 years old; 3. Head and neck squamous cell carcinoma confirmed by histopathology or cytology, including oral cancer, oropharyngeal cancer's disease, hypopharyngeal cancer, laryngeal cancer, etc. (excluding nasopharyngeal cancer); 4. Clinical stages are III-IVB(HPV negative oropharyngeal cancer and other HNSCC)(AJCC, 8th edition), II-III(HPV positive oropharyngeal cancer) (AJCC, 8th edition), and recurrent or metastatic HNSCC; 5. Locally advanced patients have not received any anti-tumor treatment before, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. Recurrent or metastatic patients have not received systematic treatment for recurrent or metastatic diseases; 6. Locally advanced patients, patients with recurrence or metastasis all plan to receive immune combined chemotherapy; 7: ECOG score 0-2; 8. The functions of major organs and bone marrow are basically normal; 9: Measurable lesions (RECIST V1.1).
Exclusion criteria
Exclusion criteria: 1. Non-squamous cell carcinoma (such as adenocarcinoma, sarcoma and lymphoma), nasopharyngeal carcinoma and metastatic squamous cell carcinoma with unknown primary focus in head and neck; 2. Recently (within 4 weeks) received anti-tumor treatment or participated in other clinical trials; 3. Autoimmune diseases: Active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.) require long-term use of immunosuppressants (such as glucocorticoids and biological agents); 4. Coagulation-related diseases: known coagulation dysfunction (such as hemophilia, hereditary thrombophilia, recent history of venous thromboembolism), or using anticoagulant drugs (such as warfarin and heparin) or antiplatelet drugs (such as aspirin and clopidogrel); 5. Abnormal blood system: known blood system diseases (such as anemia, leukopenia, thrombocytopenia); 6. Complicated with serious systemic diseases: severe heart, lung, liver and renal insufficiency (for example, ALT/AST > 3 times the normal upper limit, Cr > 1.5 times the normal upper limit), or active infection (such as HIV, active hepatitis and uncontrolled bacterial/fungal infection); 7. Complicated with other malignant tumors: having a history of other malignant tumors in the past 5 years (except non-melanoma skin cancer or cured cervical carcinoma in situ); 8: pregnant or lactating women; 9. Mental disorder or inability to cooperate with study follow-up; 10: The estimated survival time is less than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;objective response rate; | — |
Countries
China
Contacts
Beijing Tongren Hospital, Capital Medical University