nasopharyngeal carcinoma
Conditions
Interventions
treatment group:Penpulima and Capecitabine rhythmic chemotherapy
Sponsors
Neijiang Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) With the consent of the patient, it was diagnosed with nasopharyngeal carcinoma through pathological examination and the first diagnosis was made. (2) Age 18-70 years old, with a PS score of 0-1. (3) Locally advanced stage III-IVA nasopharyngeal carcinoma (T4, N3, or N2, staging standard AJCC 8th version). (4) The patient has no history of immune diseases, immunodeficiency diseases, organ transplants, or other tumors. (5) In the past three months, there have been no use of immune enhancing or inhibiting drugs, no use of glucocorticoids or non steroidal drugs. (6) Important organ function: White blood cells = 3.5 × 109/L, platelet PLT = 90 × 109/L, hemoglobin = 90g/L; Normal liver function (TBil, ALT, AST = 2.0) × ULN); Normal renal function (Ccr = 60ml/min or creatinine = 1.5 × ULN).
Exclusion criteria
Exclusion criteria: (1) Previously received nasopharyngeal or neck treatment (radiotherapy, chemotherapy, or surgery). (2) Age>65 years old or<18 years old. (3) There is a history of malignant tumors in the past, except for basal cell or squamous cell skin cancer and cervical cancer in situ that have been appropriately treated. (4) Previously received systemic anti-tumor therapy such as chemotherapy, targeted therapy, and immunotherapy. (5) Pregnancy or lactation (for women of childbearing age, pregnancy testing should be conducted and effective contraception should be emphasized during treatment). (6) Merge diseases or complications that may bring unacceptable risks or impacts, such as unstable heart disease that requires treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory diseases that require hospitalization, active hepatitis, and mental illnesses that require treatment. (7) Severe damage to important organs such as the liver, kidneys, and lungs. (8) Has undergone major surgery (excluding diagnostic surgery) within 28 days prior to treatment, or is expected to undergo major surgery during the study period. (9) History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis related to antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis, etc; Patients with autoimmune hypothyroidism who receive stable dose thyroid hormone replacement therapy are eligible to participate in this study. Patients with type 1 diabetes who have been controlled after receiving a stable insulin treatment program are eligible to participate in this study. (10) Known history of allergy to anti-tumor drugs. (11) Within the past three months, use drugs that enhance or suppress immunity, use glucocorticoids, and use non steroidal drugs. (12) Patients who have previously undergone allogeneic bone marrow transplantation or solid organ transplantation. (13) Idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia (i.e. bronchiolitis obliterans), history of idiopathic pneumonia, or evidence of active pneumonia on chest CT scans during screening. (14) According to the judgment of the researchers, the subjects may have other factors that may cause them to be forced to terminate the study midway, such as suffering from other serious diseases (including mental illness) requiring concurrent treatment, severe abnormalities in laboratory test values, family or social factors, which may affect the safety of the subjects or the collection of experimental data. (15) The researchers believe that there are other circumstances that do not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Three year relapse free survival time;Three year overall survival rate;Toxic and side effect; | — |
Countries
China
Contacts
Public ContactFeifan Lin
Neijiang Second People's Hospital
Outcome results
None listed