nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:Recombinant human p53 adenovirus injection (rAd-p53) combined with intravenous infusion of camrelizumab
Sponsors
Shenzhen Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Neck metastasis of nasopharyngeal carcinoma confirmed by histo logy or cytology; 3. Abnormal p53 gene (mutation or loss of function), abnormal p53 gene is detected by pathological immunohistochemistry or serum; 4. Progress or recurrence of standard radiotherapy or chemotherapy, and there is currently no effective anti-tumor therapy; 5. No previous use of immune checkpoint inhibitor drugs for anti-tumor therapy; 6. General condition is good (ECOG 0-2 points); 7. Blood routine, liver and kidney function, cardiopulmonary function and prothrombin time are normal; 8. The patients understood the purpose of this study, participated voluntarily and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Accompanied by severe medical diseases: (1) Nervous system: acute stroke and sequelae of cerebrovascular disease; (2) Cardiovascular system: history of uncontrolled hypertension, coronary heart disease and myocardial infarction; (3) Severe pulmonary infection or pulmonary insufficiency; (4) Obvious abnormal liver and kidney function, serum alanine aminotransferase or aspartate aminotransferase is more than 2 times higher than the upper limit of normal, and creatinine is more than 2 times higher than the upper limit of normal; 2. Patients with bleeding tendency diseases; 3. Pregnant and lactating patients; 4. Known active pulmonary tuberculosis, autoimmune disease, HIV, hepatitis B, hepatitis C or other major immunodeficiency diseases, etc.; 5. Have been less than 30 days after participating in other clinical trials or finishing other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of response;Progression-free survival; | — |
Countries
China
Contacts
Public ContactTan Wenyong
Shenzhen Hospital of Southern Medical University
Outcome results
None listed