nasopharyngeal carcinoma
Conditions
Interventions
experimental group:camrelizumab combined with gemcitabine and cisplatin as first line therapy
Sponsors
Huadong Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged from 18 to 70 years old; 2. ECOG physical condition score: 0-1; 3. Life expectancy more than 3 months; 4. Patients with advanced nasopharyngeal carcinoma diagnosed histologically or cytologically and unfit to receive local treatment; 5. No previous immune checkpoint inhibitors before; 6. No previos systematic treatment after recurrence or distant metastasis (The interval between the last neoadjuvant chemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy should be more than 6 months); 7. According to RECIST 1.1, patients should have evaluable or measurable target lesions; 8. The main organs function should meet the following standards within 7 days before treatment (no blood transfusion within 14 days before screening ): (1) hemoglobin >= 80g/L; (2) Absolute neutrophil count 1.5 x 10^9/L; (3) Platelet >= 100 x 10^9/L; (4) Total bilirubin (TBIL) = 60ml / min; (6) Blood amylase was in normal range; (7) Myocardial enzymes are in the normal range, (8) BNP is within the normal range; 9. The subjects voluntarily joined the group, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with allergies to any component of the three drugs (camrelizumab, gemcitabine and cisplatin); 2. Patients have a history of autoimmune diseases, or need oral hormone or immunosuppressant treatment; 3. Any unstable systemic disease. Including active infection, uncontrolled hypertension, unstable angina, angina pectoris that started in the last three months, congestive heart failure (>= NYHA level II), myocardial infarction (6 months before entering the group), and serious arrhythmia requiring drug treatment. 4. Patiets with other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 5. Patiets have uncontrolled intracranial metastasis or meningeal metastasis; 6. Patients who had not recovered to grade 1 after chemotherapy and radiotherapy were not included in the treatment of hair loss; 7. Previously received Immune checkpoint inhibitiors; 8. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate ;disease control rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;medicine safty; | — |
Countries
China
Contacts
Public ContactTang Xi
Huadong Hospital affiliated to Fudan University
Outcome results
None listed