recurrent/metastatic nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:SBRT+GM-CSF+PD-1 inhibitor
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily enrolled in this study and signed the informed consent form; 2. Be 18-80 years of age or older (as of the date of signing informed consent, including borderline values) and of either sex; 3. Patients enrolled must have recurrent or metastatic nasopharyngeal carcinoma that is inoperable or has progressed following the use of guideline-recommended first-line chemotherapy; note: confirmed squamous carcinoma requiring a pathology report such as histology or cytology of the original primary tumor; 4. The patient must have a measurable lesion as defined by RECIST 1.1 criteria; 5. The function of vital organs meets the following requirements (no blood components and cell growth factors are allowed for 14 d prior to enrollment*). 6. Absolute neutrophil count >= 1.5 x 109/L. 7. Platelets >= 100×109/L. 8. Hemoglobin >= 9 g/dL. 9. Bilirubin = 50 mL/min. 12. no congestive heart failure, unstable angina, or unstable arrhythmia within the last 6 months. 13. an ECOG physical status score of 0-3 and a life expectancy assessment of > 3 months 14. no previous history of immune disease. 15. able to comply with the protocol for the duration of the study 16. male or female patients of childbearing potential voluntarily use an effective method of contraception, such as a double barrier method, condoms, oral or injectable contraceptives, IUDs, etc., during the study period and within 6 months of the last study dose. All female patients will be considered fertile unless the female patient is spontaneously menopausal, has undergone artificial menopause, or has undergone sterilization (e.g., hysterectomy, bilateral adnexal resection, or radiation ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Patients presenting with any of the following will not be enrolled in this study; 2. Pathological type of neuroendocrine or small cell carcinoma and other adenocarcinomas; 3. Subjects with untreated CNS metastases; previous treatment (radiation or surgery) for systemic, radical brain or meningeal metastases may be included if imaging confirms that stability has been maintained for at least 1 month and systemic hormone therapy (dose >10 mg/day prednisone or other equivalent hormone) has been discontinued for >2 weeks with no clinical evidence; 4. Have received prior treatment with other anti-PD-1 antibodies or other PD-1/PD-L1-specific therapy; 5. The patient is on immunosuppressive or systemic hormone therapy for immunosuppression (doses greater than 10 mg/day of prednisone or other equivalent hormone) and is still on it within 2 weeks prior to enrollment; 6. The patient has any active autoimmune disease or a history of autoimmune disease; 7. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure New York Heart Association (NYHA) class > 2; ventricular arrhythmias requiring pharmacologic treatment; LVEF (left ventricular ejection fraction) 1.5 or Partial Activated Thromboplastin Time (APTT) > 1.5 x ULN), those with bleeding tendencies (e.g. active ulcerative lesions in the stomach, occult blood in the stool (++), black stool and/or vomiting blood within 3 months, hemoptysis) or those with lesions in close proximity to encircling large blood vessels, lesions involving the skin or mucosal cavity at risk of rupture; 13. Patients with current hypertension not controlled by medication, specified as: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg; 14. Urine routine suggesting urine protein >= 2+ and 24-hour urine protein amount > 1.0 g; 15. A corrected QT interval > 470 msec; if the patient has a prolonged QT interval, but the cause of the prolongation is assessed by the investigator study to be a pacemaker (and there are no other cardiac abnormalities), it is up to the investigator to determine whether the patient is a suitable candidate for enrollment in the study; 16. Other malignancies within the past 5 years, except for basal or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; 17. Known hypersensitivity to drug components; 18. Unremitting toxic reactions above CTCAE v5.0 grade 1 due to any prior anticancer therapy, excluding alopecia, lympho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;Duration of reaction;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactSufang Qiu
Outcome results
None listed