nasopharyngeal carcinoma
Conditions
Interventions
Case series:camrelizumab combined with concurrent radiotherapy and chemotherapy
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with non-keratinizing nasopharyngeal carcinoma (poorly differentiated, undifferentiated carcinoma) diagnosed by pathology or clinical diagnosis; 2. The eighth edition of UICC/AJCC TNM is staged as stage II-IVa (stage II is only T2N1M0); 3. Have not received surgery, radiotherapy, system therapy, immunotherapy in the past; 4. Have measurable tumor lesions (spiral CT scan >=10mm, meet RECIST 1.1 standard); 5. Expected survival time > 3 months; 6. Aged 18 to 70 years; 7. ECOG PS 0-2 points; 8. The functions of vital organs meet the following requirements: 1) Absolute neutrophil count >= 1.5 x 10^9/L, platelet >= 100 x 10^9/L, hemoglobin >= 9g/dL; 2) Bilirubin 35g/ml, prothrombin time extension 60 mL/min; 9. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to use it uninterruptedly during treatment and 6 months after the last therapeutic dose is administered. Contraceptive measures; 10. The patient voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffer from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. Patients with bone marrow suppression or coagulation disorders and patients with renal impairment; 3. Active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before medication should be excluded even if they have been treated. Patients with a history of active pulmonary tuberculosis infection more than 1 year ago are also excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment; 4. Patients with active hepatitis B or C, and chronically infected patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with a viral load of less than 2000 IU/mL are allowed to participate in the study, but are required during the study period Continue or start the full course of standardized antiviral therapy; 5. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or hair loss) Can be selected; 6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; 7. Patients receiving hematopoietic stem cell or organ transplantation; 8. Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Carrelizumab. 9. Pregnant or lactating women; 10. Patients who cannot follow the trial protocol or cannot cooperate with follow-up; 11. Have a history of psychotropic drug abuse, alcohol or drug abuse; 12. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 13. The researcher thinks it is inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 36-DFS;OS;safety; | — |
Countries
China
Contacts
Public ContactZhenbin Zhong
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed