Oligometastatic Nasopharyngeal Carcinoma
Conditions
Interventions
Experimental Group:SBRT in combination with PD-1 inhibitor immunotherapy
Control Group:maintenance therapy with PD-1 inhibitor alone
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 years - 70 years. 2. The primary lesion and cervical lymph nodes have undergone radical dose radiotherapy. The time elapsed since the start of SBRT treatment is more than 3 months and the disease control is good. 3. At least received first-line systemic chemotherapy, regardless of the chemotherapy regimen and efficacy. 4. On imaging, oligometastatic lesions were detected (biopsy of metastatic tissue is preferred but not mandatory). The total number of metastatic lesions does not exceed 5, and the number of single-organ metastatic lesions is <= 3. 5. ECOG score is 0-1. 6. All metastatic lesions can be treated with SBRT through multidisciplinary consultation. 7. For patients who have received local treatment for metastatic lesions (such as surgery, radiofrequency ablation, radiotherapy); 8. The maximum diameter of brain metastases <= 3 cm. 9. The maximum diameter of metastatic lesions outside the brain <= 5 cm.
Exclusion criteria
Exclusion criteria: 1. Patients who failed immunotherapy (anti-PD-1/PD-L1 antibody or anti-CTLA-4 antibody immunotherapy). 2. Patients with coronary heart disease of grade >= II, arrhythmia (including QTc interval prolongation in males > 450 ms, females > 470 ms) and cardiac insufficiency. 3. Those with a history of severe hypersensitivity reaction to any component of PD-1/PD-L1 monoclonal antibodies or other monoclonal antibodies. 4. Those who received chemotherapy (cytotoxic or molecular targeted drugs) within 4 weeks before SBRT treatment. 5. Patients with spinal cord compression indicated by clinical or radiological evidence, or with tumor distance from the spinal cord < 3 mm. 6. Patients with brain metastases requiring surgical decompression. 7. Patients with malignant pleural effusion or with other malignant tumors. 8. Patients with known or suspected autoimmune diseases, including dementia and seizure. 9. Those who received high-dose glucocorticoid treatment within 4 weeks before enrollment. 10. Patients with comorbidities requiring long-term use of immunosuppressive drugs, or requiring systemic or local use of corticosteroids at immunosuppressive doses. 11. Patients with active pulmonary tuberculosis (TB), who are undergoing anti-TB treatment or have received anti-TB treatment within 1 year before screening. 12. Subjects with any active autoimmune disease or with a history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or who had completely resolved childhood asthma and do not require any intervention after adulthood can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included). 13. HIV-positive individuals; HBsAg-positive and HBV DNA copy number positive (quantitative detection = 1000 cps/ml); positive for chronic hepatitis C blood screening (HCV antibody positive). 14. Those who received any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment. 15. Pregnant women with positive pregnancy test and lactating women. 16. Other patients considered unsuitable for inclusion by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival (mPFS);Quality of life (QoL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate,CBR;Safety outcomes;Overall survival, OS;DCR,Disease control rate;Objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactYou Rui
Fifth Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed