Advanced nasopharyngeal carcinoma in a high-risk localized area
Conditions
Interventions
Control group:induction chemotherapy followed by systemic therapy/RT
Interventional group:PD-1/CTLA-4 bi-specific Antibody combined with chemoradiotherapy
Sponsors
Sun Yat-sen University Cancer Prevention and Treatment Center (Sun Yat-sen University Affiliated Cancer Hospital, Sun Yat-sen University Cancer Research Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed age: 18-65 years old; 2. Newly diagnosed nasopharyngeal carcinoma with pathological diagnosis of "non keratinizing carcinoma (WHO standard)"; According to the 9th edition clinical staging system of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC), the diagnosis is locally advanced nasopharyngeal carcinoma (T4N1 and T1-4N2-3). All subjects must undergo the following examinations to determine clinical staging before the first treatment: complete medical history, physical examination, blood and biochemical routine, plasma EBV DNA titers and serological tests, nasopharyngoscopy, head and neck magnetic resonance imaging (MRI), chest X-ray or computed to tomography (CT), abdominal ultrasound, and bone imaging. In addition, 18F fluorodeoxyglucose positron emission tomography/CT (PET/CT) can be used as an alternative to the last three imaging examinations mentioned above; 4. ECOG score: 0-1 points (Appendix I); 5. Normal bone marrow function: white blood cell count>4 × 10 ^ 9/L, hemoglobin concentration>90g/L, platelet count>100 × 10 ^ 9/L; 6. Normal liver and kidney function: total bilirubin=60 mL/min; 7. Thyroid function, amylase and lipase, pituitary function, inflammatory infection indicators, myocardial enzymes, and electrocardiogram results are normal; For patients over 50 years old with a history of smoking, normal lung function test results are required; For patients with abnormal electrocardiograms or a history of cardiovascular disease (but not meeting exclusion criteria), additional myocardial function tests and cardiac ultrasound examinations are required, and normal results are required; 8. Participants must sign an informed consent form and must be willing and able to comply with the visit, treatment plan, laboratory tests, and other requirements specified in the research protocol; 9. Female subjects with reproductive ability and male subjects with reproductive partners must agree to use reliable contraceptive measures (such as condoms, regularly prescribed birth control pills) within one year after screening and treatment.
Exclusion criteria
Exclusion criteria: 1. HBsAg is positive and hepatitis B B virus quantity is>1 × 10 ^ 3 copies/ml, or anti hepatitis C virus antibody is positive; 2. Positive anti HIV antibody or acquired immunodeficiency syndrome (AIDS); 3. Active pulmonary tuberculosis: patients with active tuberculosis history in the past 1 year should be excluded regardless of treatment; 4. Except for patients who have been confirmed to have received regular anti tuberculosis treatment in the past, patients with active tuberculosis history of more than one year should be excluded; 5. Active, known or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, pituitary diseases, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilation). Excluding type I diabetes, hypothyroidism requiring hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia); Clinical doctors need to conduct necessary medical history inquiries, physical examinations, tests, and examinations for the above-mentioned diseases before enrollment to exclude them; 6. Suffering from interstitial lung disease or pneumonia within the past year requiring oral or intravenous steroid treatment; 7. Chronic systemic corticosteroid (dose equal to or exceeding 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who inhale or apply corticosteroids topically are eligible; 8. Uncontrolled heart disease, such as: (1) heart failure, NYHA level>=2; (2) Unstable angina pectoris; (3) History of myocardial infarction in the past year; (4) Supraventricular arrhythmias or ventricular arrhythmias that require treatment or intervention; 9. Pregnant or lactating women (pregnancy tests should be considered for sexually active women of childbearing age); 10. Except for fully treated non melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma, those who have previously or currently suffered from other malignant tumors; 11. It is known that the subject has a history of allergies to large molecule protein preparations or any components of aparolithovirizumab; 12. Active infections that require systemic treatment within one week; 13. Receive a live vaccine within 30 days prior to the first dose of aparolithovir monoclonal antibody; 14. History of organ transplantation; 15. Other situations assessed by researchers that may endanger patient safety or compliance, such as serious illnesses (including mental illnesses) that require timely treatment, severe abnormal test results, and other family or social high-risk factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure-free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| No localized area failure survival;No distant transfer failed survival.; | — |
Countries
China
Contacts
Public ContactJun Ma
Sun Yat-sen University Cancer Prevention and Treatment Center (Sun Yat-sen University Affiliated Cancer Hospital, Sun Yat-sen University Cancer Research Institute)
Outcome results
None listed