Nasopharyngeal carcinoma
Conditions
Interventions
Experimental group: All subjects received a comprehensive treatment regimen of "chemoradiotherapy combined with immunotherapy and stereotactic body radiation therapy (SBRT) for metastatic lesions.":ch
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed age: 18 - 70 years old; 2. Newly diagnosed nasopharyngeal carcinoma pathologically confirmed as "non - keratinizing carcinoma(WHO criteria)"; 3. Metastatic nasopharyngeal carcinoma diagnosed according to the 9th edition of the American Joint Committee on Cancer clinical staging system (T1 - 4N0 - 3M1); 4. ECOG score: 0 - 1; 5. Can accept SBRT treatment for metastatic lesions as comprehensively evaluated by doctors; 6. At least 1 measurable lesion meeting the RECIST 1.1 criteria; 7. Normal bone marrow function: white blood cell count > 4×10^9/L, hemoglobin concentration > 90g/L, platelet count > 100×10^9/L; 8. Normal liver and kidney function: total bilirubin =60 mL/min; 9. Normal results of thyroid function, amylase, lipase, pituitary function, inflammatory infection indicators, myocardial enzymes, and electrocardiogram examinations; for patients over 50 years old with a smoking history, normal pulmonary function test results are required; for patients with abnormal electrocardiogram or previous cardiovascular disease history (but not meeting the items listed in exclusion criterion 7), additional myocardial function tests and cardiac color Doppler ultrasound examinations are required, and the results must be normal; 10. Patients must sign an informed consent form and be willing and able to comply with the follow - up, treatment, laboratory testing and other research requirements specified in the study schedule; 11. Female subjects of childbearing age must agree to use reliable contraceptive measures (such as condoms, contraceptives used regularly as prescribed by doctors) from screening to 1 year after treatment.
Exclusion criteria
Exclusion criteria: 1. Positive for hepatitis B surface antigen and hepatitis B virus load > 1×10^3copies/mL, or positive for anti-hepatitis C virus antibody; 2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (i.e., AIDS); 3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded, regardless of treatment status. Patients with a history of active pulmonary tuberculosis for more than 1 year should be excluded, except those who have been confirmed to have received regular anti-tuberculosis treatment in the past; 4. Active, known, or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, pituitary diseases, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilation). Exceptions include type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia); 5. A history of interstitial lung disease or pneumonia within the past year that required oral or intravenous steroid treatment; 6. Chronic systemic glucocorticoid therapy (at a dose equal to or exceeding 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects receiving inhaled or topical corticosteroids are eligible; 7. Uncontrolled heart disease, such as (1) Heart failure with NYHA class >= 2; (2) Unstable angina; (3) A history of myocardial infarction within the past year; (4) Supraventricular or ventricular arrhythmias requiring treatment or intervention; 8. Pregnant or lactating women (pregnancy tests should be considered for sexually active women of childbearing age); 9. A past or current history of other malignant tumors, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid cancer; 10. Allergy to macromolecular protein preparations or any component of PD-1 monoclonal antibodies; 11. Active infection within 1 week requiring systemic treatment; 12. Receipt of live vaccines within 30 days before the first course of PD-1 monoclonal antibody; 13. A history of organ transplantation; 14. Urinalysis indicating urine protein >= ++, and confirmed 24-hour urine protein >= 1.0 g; 15. Other conditions assessed by researchers that may endanger patient safety or compliance, such as severe diseases requiring timely treatment (including mental illness), significantly abnormal test results, and other psychological, family, or social high-risk factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure-Free Survival (FFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Local regional Failure-Free Survival;Distant Metastasis-Free Survival;Disease Control Rate;Overall Survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactZhou Guanqun
Sun Yat-sen University Cancer Center
Outcome results
None listed