nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:metronomic chemotherapy
Sponsors
Jiangmen Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathological diagnosis of nasopharyngeal carcinoma by biopsy of the primary nasopharyngeal tumor; 2. There are EBV-DNA copy number determination results before induction chemotherapy, after concurrent chemoradiotherapy, and before each consolidation therapy; 3. Aged 18 to 70 years; 4. The clinical staging standard of all patients is AJCC 8th edition stage IVA: (1) Whole body PET-CT examination (preferred recommendation) or enhanced thoracoabdominal and pelvic CT scan to exclude distant organ and bone metastasis, namely M0; (2) The staging of nasopharyngeal + neck MRI (unenhanced scan + enhanced scan) at the initial diagnosis was T4 or N3. 5. All male and female participants are required to take contraceptive measures; 6.PS status score: ECOG 0-1 points; 7. Liver and kidney function and hematopoietic function are normal; 8. Understand the entire trial and sign the consent form for enrolling in the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Received any anti-PD-1/PD-L1 therapy in the past; 2. Received radiation therapy for the head and neck in the past; 3. For female patients found to be pregnant or breastfeeding; 4. Received any anti-nasopharyngeal cancer treatment before enrollment; 5. Received any form of inactivated vaccine within 1 month before enrollment; 6. Combined with autoimmune deficiency diseases (such as HIV positive) or long-term oral hormone therapy or combined with autoimmune diseases requiring long-term oral immunosuppressive therapy (such as patients receiving organ transplantation or bone marrow transplantation); 7. Combined with the existence of the second primary cancer; 8. Patients allergic to sintilimab; 9. Patients with non-infectious pneumonia requiring hormone therapy; 10. Active hepatitis B or C infection, and are on antiviral treatment; if the previous active treatment is combined with HBV infection and the HBV is at an unmeasurable level, they can be included in the group; 11. Patients with active pulmonary tuberculosis; 12. Corticosteroids or intravenous antibiotics were used during radiotherapy and chemotherapy; 13. Patients with dihydropyrimidine dehydrogenase (DPD enzyme) deficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year Overall survival;>=3 Grade toxicities related to treatment;tolerance of treatment;3-year local area fail-free survival;3-year survival without distant metastasis;3-year disease free survival; | — |
Countries
China
Contacts
Public ContactXiao Lin
Jiangmen Central Hospital
Outcome results
None listed