nasopharyngeal carcinoma
Conditions
Interventions
Treatment group:Cetuximab ß combined with Tislelizumab and chemotherapy
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed nasopharyngeal carcinoma with differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma. 2. Clinical stage of stage II-III nasopharyngeal carcinoma (excluding T3-4N0 and T3N1 patients with positive retropharyngeal lymph nodes only) (according to the ninth edition of AJCC staging criteria) (Note: Patients should undergo enhanced magnetic resonance (MRI) examination of the nasopharynx and neck for staging before treatment; If the patient has contraindications to MRI, enhanced computed tomography (CT) is also acceptable. Tests to rule out distant metastases include chest x-rays, liver ultrasound, and whole-body bone scintigraphies, and can also be enhanced CT/MRI or PET/CT). 3. ECOG performance status score (PS score) 0 or 1 (Appendix 2). 4. Age 18-70 years old, no serious heart, lung, liver, kidney and other important organ dysfunction. 5. No chemotherapy or radiotherapy related to nasopharyngeal cancer before enrollment. 6. Laboratory indicators: white blood cell > 3.0×10^9/L, neutrophil > 1.5×10^9/L, platelet count >100×10^9/L, hemoglobin >90g/L; Serum total bilirubin =60mL/min; The upper limit of the normal value of APTT for coagulation parameters was extended by no more than 10 seconds, and the upper limit of normal value of PT was extended by no more than 3 seconds. 7. Female subjects of childbearing potential must agree to use reliable contraception from the screening visit to 1 year after the last dose of PD-1 monoclonal antibody; Male subjects with female partners of childbearing potential must agree to use reliable contraception from the screening visit until 1 year after the last dose of PD-1 monoclonal antibody. 8. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant (confirmed by menstrual blood or urine HCG test) or lactating women, or subjects of childbearing age are unwilling or unable to take effective contraceptive measures (both for male and female subjects) until at least 6 months after the last trial treatment; 2. Those who have a history of allergy to the macromolecular protein preparations used in this regimen or any component of cetuximab ß tislelizumab; 3. Central nervous system metastases with cerebral edema, requiring hormone intervention, or progression of brain metastases; 4. History of other malignant tumors within or at the same time within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid cancer; 5. Has received any of the following treatments: (1). Received PD-1\PD-L1 inhibitors, CTLA-4 antibodies, EGFR monoclonal antibodies, EGFR-TKIs, and anti-angiogenic drugs within 4 weeks; (2). Received any investigational drug experiment within 4 weeks before the first use of the study drug; (3). Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; (4). Subjects who have received systemic hormones or other immunosuppressive therapy at an equivalent dose >10mgprednisone/day or other immunosuppressive therapy within 28 days before signing the informed consent form, and subjects with systemic hormone doses <=10mgprednisone/day or inhaled/topical corticosteroids can be enrolled; (5). Received anti-tumor vaccine or live vaccine within 4 weeks before the first dose of study drug; (6). Major surgery or severe trauma within 4 weeks before the first use of the study drug. 6. Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 7. Serious infection (CTC AE greater than grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection comorbidities, etc. requiring hospitalization; Baseline chest imaging suggests active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of study drug, or need for oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use); 8. History of interstitial lung disease and non-infectious pneumonitis; 9. Patients with active tuberculosis infection found through medical history or CT examination, or a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection 1 year ago but without formal treatment; 10. Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); Autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; Diabetes mellitus using a stable dose of insulin; However, it does not include patients with vitiligo or cured childhood asthma/allergies who do not require any intervention after adulthood; 11. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and bone marro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate, CR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;3-year Distant Metastasis Free Survival ;3-year Locoregional Relapse-free Survival;3-year Progression-free Survival;3-year Overall Survival;Quality of life; | — |
Countries
China
Contacts
Public ContactGuoyi Zhang
The First People's Hospital of Foshan
Outcome results
None listed