nasopharyngeal carcinoma
Conditions
Interventions
experimental group:Stage of induction traetment: 3 cycles of PD-1 inhibitor (200mg,d0,q3w) plus nimotuzumab (100mg,d0?d8,q3w) and chemotherapy (gemcitabine, 1000 mg/m2,d1?d8
cisplatin, 80mg/m2, d1,q3w), 21 days is a cycle. Stage of Concurrent treatment: cisplatin, 80mg/m2,d1,q3w, 2cycles
nimotuzumab 200mg,d1,qw
radiotherapy for nasopharynx and cervical metastatic lymph node. Stage of adjuvant treatment: Capecitabine (650mg/m2, take orally, two times every day) until 1 year or the end of the study.
Sponsors
The Tenth Affiliated Hospital of Southern Medical University (Dongguan people's hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients pathologically diagnosed with nasopharyngeal carcinoma; (2) Patients newly diagnosed with advanced nasopharyngeal carcinoma at Stage T3-4N3M0 defined by the American Journal of Critical Care (AJCC) staging system (the 8th edition) by two or more experienced radiation oncologists or radiologists; (3) Patients who have not received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc; (4) Aged = 18 years and = 65 years; (5) The Eastern Cooperative Oncology Group (ECOG) score: 0~1 point; (6) The function of vital organs meet the following requirements (it is not allowed to use any blood component, cell growth factors, white blood cell-increasing drugs, platelet-increasing drugs, and drugs to correct anemia within 14 days prior to the first dose of the study drug) a. Absolute neutrophil count (ANC) = 1.5 × 10^9/L; Hemoglobin = 90 g/L; Platelet count = 100 × 10^9/L; b. ALT and/or AST = 2.5 × ULN, ALT and/or AST = 5 × ULN, total bilirubin = 1.5 × ULN, ALP < 2.5 × ULN c. Creatinine clearance =50 mL/min (Cockcroft-Gault); d. APTT=1.5×ULN, INR=1.5×ULN (Patiants receiving stable doses of anticoagulation therapy, such as low molecular weight heparin or warfarin, and whose INR falls within the expected therapeutic range, may be eligible for screening.) (7) Patients who have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and the lesion should not have received radiotherapy or other local treatment; (8) Expected survival =12 weeks; (9) Female subjects with childbearing potential and male subjects whose partners are women of childbearing age should take one medically recognized contraceptive measure during the study treatment period, at least 3 months after the last dose of camrelizumab, and at least 6 months after the last use of chemotherapy; (10) Subjects who are voluntary to join the study, sign the informed consent form, have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: (1) Patients with a past history of allergy to any component of PD-1 inhibitor, nimotuzumab, gemcitabine, cisplatin and capecitabine or its components; (2) Patients previously before 5 years or concurrently suffering from other malignant tumors (except for malignant tumors which have been cured with cancer-free survival of more than 5 years, such as cutaneous basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, etc.); (3) Patients who participated in another clinical study at the same time, except for the observational study; (4) Patients with uncontrolled cardiac clinical symptoms or diseases, such as: a. NYHA grade II or higher heart failure; b. unstable angina; c. myocardial infarction that has occurred in the past 1 year; d. supraventricular or ventricular arrhythmia with clinical significance and requiring clinical intervention; (5) Patients who have received any of the following treatments: a. Patients who have previously received anti-PD-1, anti-PD-1 antibody or anti-CTLA-4 antibody treatment; b. Patients who are concurrently enrolled into another clinical study, unless the study is observational (non-interventional) clinical study or interventional clinical study follow-up; c. Subjects who need to receive systematic treatment with corticosteroids (>10 mg prednisone equivalent dose/day) or other immunosuppressive agents, except for the use of corticosteroids for local inflammation and prevention of allergies and nausea and vomiting. Other special cases require communication with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal cortical hormone replacement therapy with at a dose >10 mg/day therapeutically effective dose of prednisone are allowed; d. Patients who have received inoculation of tumor vaccines or have received live vaccines within 4 weeks prior to the first dose of the study drug; e. Patients who have undergone major surgery or had a severe trauma within 4 weeks prior to the first dose of the study drug; (6) Patients who have developed severe infection (CTC AE > grade 2) within 4 weeks prior to the first dose of the study drug, such as severe pneumonia, bacteremia and complication of infection that require hospitalization; patients whose baseline chest imaging findings suggest active pulmonary inflammation, or patients with symptoms and signs of infection within 2 weeks prior to the first dose of the study drug or need to be treated with oral or intravenous antibiotics (excluding prophylactic use of antibiotics); (7) Patients with active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism, including but not limited to these diseases or syndromes); but excluding autoimmune-mediated hypothyroidism using a stable dose of thyroid replacement hormone therapy; type I diabetes using a stable dose of insulin; patients with vitiligo or cured childhood asthma/allergy that does not require any intervention after adulthood; (8) Patients with a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and a history of allogeneic bone marrow transplantation; (9) Patients with a history of interstitial lung disease (excluding radiation pneumonitis without hormone therapy),history of non-infectious pneumonia; (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year Progression-free Survival (PFS ) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS);Overall Survival (OS);Two-year locoregional recurrence free survival (LRRFS) rate;Two-year distant metastasis-free survival (DMFS) rate;Objective response rate (ORR) after induction therapy;Safety; | — |
Countries
China
Contacts
Public ContactZhigang Liu
The Tenth Affiliated Hospital of Southern Medical University (Dongguan people's hospital)
Outcome results
None listed