nasopharyngeal carcinoma
Conditions
Interventions
Group 1 :sintilimab combined nimotuzumab
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent prior to implementing any trial-related procedures; 2. No gender limitation, age >= 18 years; 3. Histological or cytological assessment of stage III-IVA local advanced nasopharyngeal carcinoma (American Joint Commission on Cancer/International Joint Commission on Cancer Control, Edition 8); 4. According to the efficacy evaluation criteria for solid tumors (RECIST version 1.1), at least one lesion can be measured on imaging; 5. Plan to receive induction therapy and concurrent radiotherapy +/- sintilimab untreated locally advanced nasopharyngeal carcinoma; 6. ECOG PS score 0-1; 7. Expected survival time > 6 months; 8. Adequate organ function.
Exclusion criteria
Exclusion criteria: 1. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first administration; 2. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulating or co-inhibiting T cell receptor (eg, CTLA-4, OX-40, CD137) drug; 3. Received systemic treatment with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin) within 2 weeks before the first administration; 4. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 5. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other routes of topical glucocorticoid) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Those who are known to be allergic to the active ingredients or excipients of the study drug sintilimab, and the study chemotherapy drugs; 8. Has not fully recovered from toxicity and/or complications caused by any intervention (ie, <= grade 1 or reached baseline, excluding fatigue or alopecia) before starting treatment; 9. Known history of human immunodeficiency virus (HIV) infection (ie HIV1/2 antibody positive); 10. Untreated active hepatitis B; 11. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection); 12. Received live vaccine within 30 days before the first dose (cycle 1, day 1) (Note: Injectable inactivated virus vaccine against seasonal influenza is allowed within 30 days before the first dose; but intranasal administration is not allowed live attenuated influenza vaccine.); 13. Pregnant or lactating women; 14. There are any serious or uncontrollable systemic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, Objective Response Rate;Adverse effects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival rate;Progression-free survival, PFS;Quality of life; | — |
Countries
China
Contacts
Public ContactXiaojun Zhong
The First Affiliated Hospital of Nanchang University
Outcome results
None listed