distant metastatic nasopharyngeal carcinoma
Conditions
Interventions
experimental group:GP regimen combined with carrelizumab treatment + IMRT simultaneous carrelizumab + cisplatin treatment
Sponsors
Guizhou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years. 2. Can provide past tumor specimens or fresh tumor tissue biopsy samples. 3. Nasopharyngeal carcinoma confirmed by histology or cytology. 4. The staging is TxNxM1 (according to the eighth edition of the AJCC staging standard) (Appendix I). 5. According to the RECIST 1.1 evaluation criteria, there is at least one measurable lesion. 6. The expected survival period is >=6 months. 7. According to the Eastern Cooperative Oncology Group (ECOG) standard (Appendix 3), the physical status score is 0 or 1. 8. Good organ function: (1) Hematology: white blood cell >=4.0 x 10^9/L, absolute neutrophil count >=2.00 x 10^9/L, hemoglobin >=90 g/L, platelet >=100.0 x 10^9/L. (2) Liver function: Bilirubin = 3g / dL; (3) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) =60 mL/min. 9. Willing and able to comply with research plan visits, treatment plans, laboratory examinations and other research procedures. 10. Female patients who meet the following criteria are eligible to be selected and participate in the study: Women who are infertile (such as physically unable to become pregnant) and meet any of the following conditions: (1) Hysterectomy has been performed. (2) Bilateral oophorectomy (oophorectomy) has been performed. (3) Bilateral fallopian tube ligation has been performed. (4) After menopause (total time of menopause >= 1 year). (5) With fertility, at the time of screening (within 7 days before the first administration of the study drug), the serum pregnancy test was negative, and adequate pregnancy prevention measures were taken from before entering the study and during the entire study period until 60 days after the last administration of the study drug. Adequate contraceptive measures taken continuously in accordance with the instructions of the contraceptive product and the doctor's instructions are defined as follows: 1) Intrauterine devices that have proved that the contraceptive failure rate is lower than 1% per year; 2) Double barrier contraception refers to condoms with spermicidal jelly, foam, suppository or film; or contraceptive membranes with spermicide; or condoms and contraceptive membranes for men.
Exclusion criteria
Exclusion criteria: 1. HBsAg positive and HBV DNA >200IU/ml or 1000 copies/ml (for HBcAb-positive patients, HBV DNA testing is also recommended; if HBsAg is positive, even if HBV DNA is 0, you must receive preventive antiviral therapy). 2. HCV antibody is positive. 3. Active, known or suspected autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, Sjogrens syndrome, ulcerative colitis, Crohns disease, myasthenia gravis, Hashimotos thyroiditis and Graves disease. Subjects with type I diabetes, hypothyroidism that requires only hormone replacement therapy, and skin diseases that do not require systemic therapy (such as vitiligo, psoriasis, or hair loss) can be selected. 4. Received systemic hormone or other immunosuppressive therapy with an equivalent dose of> 10 mg prednisone/day within 28 days before signing the informed consent. Subjects with a systemic hormone dose = 10 mg prednisone/day or inhaled/topical corticosteroids can be selected. 5. There is active tuberculosis infection. Patients with active tuberculosis infection in the previous year should be excluded even if they have been treated; patients with a history of active tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment. 6. There is a history of interstitial lung disease. 7. Live vaccines have been vaccinated or will be vaccinated within 30 days before signing the informed consent. 8. Women who are breastfeeding. 9. Suffered from other malignant tumors within 5 years, excluding carcinoma in situ, fully treated non-melanoma skin cancer and papillary thyroid carcinoma. 10. The subject is known to have been allergic to macromolecular protein preparations or any components of PD1 preparations. 11. Human immunodeficiency virus (HIV) infection. 12. Other conditions judged by the investigator that may affect the safety of the subjects or the compliance of the trial, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic treatment, mental illness, or family and society factor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;duration of relief;one year progression-free survival;2 years progression-free survival;one year overall survival rate; 2 years overall survival rate; | — |
Countries
China
Contacts
Public ContactGong Xiuyun
Guizhou Cancer Hospital
Outcome results
None listed