nasopharyngeal carcinoma
Conditions
Interventions
experimental group:The first stage is the PD-1 inhibitor plus nimotuzumab and chemotherapy combination treatment, 21 days is a cycle, a total of 4-6 cycles, and the specific discription is: PD-1 inhib
Nimotuzumab, intravenous infusion, on day 0 (one day before chemotherapy)
Chemotherapy: Gemcitabine, intravenous infusion, day 1 and 8, (1000mg/m2), Cisplatin, intravenous infusion, day 1 (80mg/ m2). The second stage is the maintenance treatment, and the specific discriptio
Capecitabine (650mg/m2, take orally, two times every day)
PD-1 inhibitor and Capecitabine should be administered until the end of the study.
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients pathologically diagnosed with nasopharyngeal carcinoma; (2) Patients newly diagnosed with advanced nasopharyngeal carcinoma at Stage IVb defined by the American Journal of Critical Care (AJCC) staging system (the 8th edition), or relapsed nasopharyngeal carcinoma not suitable for local treatment. Local treatment mainly refers to anti-tumor treatment-related measures, including surgery, radiofrequency ablation, transcatheter arterial chemoembolization (TACE), radiotherapy (except for radiotherapy at local appropriate doses for the relief of symptoms that does not affect blood pictures in patients with bone metastases); (3) Patients who have not received chemotherapy for relapsed or metastatic nasopharyngeal carcinoma (except for patients whose disease progressed more than 6 months after the receipt of neoadjuvant chemotherapy, adjuvant chemotherapy, or radical concurrent chemoradiotherapy); (4) 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; (5) Aged = 18 years and = 75 years; (6) The Eastern Cooperative Oncology Group (ECOG) score: 0~1 point; (7) 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; Platelet count = 100 × 10^9/L; Hemoglobin = 90 g/L; b. Total bilirubin = 1.5 × ULN, c. ALT and/or AST = 2.5 × ULN; if there is liver metastasis, ALT and/or AST = 5 × ULN; d. Serum creatinine =1.5 × ULN or creatinine clearance =50 mL/min (Cockcroft-Gault); (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 (IUD, birth control pills or condoms) during the study treatment, period, at least 3 months after the last dose of camrelizumab/placebo, 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, gemcitabine, cisplatin and capecitabine or its components; (2) Locally advanced patients who can receive radical treatment such as surgery, radical radiotherapy or radical radiochemotherapy; (3) Patients with clinically symptomatic central nervous system metastases such as cerebral edema and requiring hormone intervention, or progression of brain metastases. Patients who have previously received brain or meningeal metastasis treatment, if they are stable both as shown by MRI and clinically (do not require > 10 mg/day prednisone or equivalent dose of hormone therapy), can be included; (4) Patients previously 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.); (5) Patients who participated in another clinical study at the same time, except for the observational study; (6) 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; (7) 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; (8) 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); (9) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year PFS Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS);Overall Survival (OS);Objective Response Rate (ORR) ;Disease Control Rate (DCR);Safety; | — |
Countries
China
Contacts
Public ContactZhigang Liu
Dongguan people's hospital
Outcome results
None listed