Nasopharyngeal Carcinoma
Conditions
Interventions
Experimental group:Systemic treatment period: 4-6 cycles of gemcitabine + cisplatin + camrelizumab treatment (specifically: (1g/m^2, intravenous infusion, Day1, Day 8, every 3 weeks) + cisplatin (80 m
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-75 2. Patients with locally advanced nasopharyngeal carcinoma who have relapsed or metastasized nasopharyngeal carcinoma (classified as AJCC stage IVb) or have local recurrence after radical radiotherapy and are not suitable for radical treatments such as surgery, radical radiotherapy, or radical chemoradiotherapy; 3.ECOG score: 0-1 point; 4. Expected survival time >=12 weeks; 5. According to RECIST1.1 standards, there is at least one measurable lesion; 6. Have good organ function. Good organ function can be referred to as follows: White blood cell count >= 4.0 ×10^9/L; Neutrophils >=2.0×10^9/L; Hb>=90 g/L; Platelet count >=100×10^9/L; Total bilirubin <=1.5 times the upper limit of the normal (ULN), AST and ALT < 2.5 times ULN, AKP<=2.5 times ULN; If liver metastasis exists, AST and ALT should be less than or equal to 5 times ULN. If there is liver metastasis or brain metastasis, AKP should be less than or equal to 5 times ULN. Creatinine is 1.5 times lower than the upper limit of normal or the creatinine clearance rate is greater than 60mL/min(Cockcroft-Gault male creatinine clearance rate =[(140 - years of age)×Weight (kg)]/ [72×serum Creatinine (mg/dL), female creatinine clearance rate =0.85* male creatinine clearance rate; Activated partial thromboplastin activity time (APTT) and international normalized ratio (INR)<=1.5 × ULN(patients who can be enrolled in steady-dose anticoagulant therapy such as low-molecular-weight heparin or warfarin, with INR within the expected therapeutic range of anticoagulant drugs); 7. Patients who have received systemic treatment (camrelizumab combined with GP chemotherapy) for no more than 6 cycles and whose basic conditions meet the above inclusion and exclusion criteria without the following exclusion criteria, and whose data before and after combined treatment can meet the research requirements, may be included in the study. 8. Patients who voluntarily participate in this clinical study, sign the informed consent form and are able to comply with the visit schedule, treatment plan, laboratory tests and other research procedures.
Exclusion criteria
Exclusion criteria: Patients with a history of allergy to camrelizumab, gemcitabine, cisplatin and any component of other platinum-based drugs; 2. Having received other systemic treatments related to recurrent or metastatic nasopharyngeal carcinoma after recurrence or metastasis; 3. Patients with uncontrollable clinical symptoms or diseases of the heart, such as NYHA grade II or above heart failure; Unstable angina pectoris Myocardial infarction that occurred within the past year; Supraventricular or ventricular arrhythmias with clinical significance and requiring clinical intervention; 4. Patients with a history of immune deficiency, including those who are HIV positive, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation; 5. Patients with a history of interstitial lung disease (excluding radiation pneumonitis without hormone therapy) and non-infectious pneumonia; 6. Patients with a history of active tuberculosis infection detected by previous medical history or CT examination, or those with a history of active tuberculosis infection within one year before enrollment, or those with a history of active tuberculosis infection more than one year before enrollment and who have not received standardized treatment; 7. Subjects with active hepatitis B (HBV DNA>=2000iu /mL or 10 copies/mL) and hepatitis C (positive hepatitis C antibody, HCV-RNA higher than the detection limit of the analytical method); 8. Malignant tumors other than nasopharyngeal carcinoma (excluding malignant tumors such as basal cell carcinoma of the skin, cervical carcinoma in situ, papillary thyroid carcinoma, Ta, Tis or T1 bladder cancer that have been cured and have been free of cancer for more than 3 years); 9. Patients who present with symptoms of central nervous system metastasis such as cerebral edema and require hormone intervention, or those with progressive brain metastasis. Patients who have previously received treatment for brain or meningeal metastases can be included if both MRI and clinical manifestations show stability (no need for prednisone > 10 mg/day or equivalent hormone therapy). 10. Pregnant or lactating women; 11. Difficulty in swallowing and inability to take oral medication; 12. Suffering from mental or psychological disorders may affect informed consent. 13. Have received clinical trials of other drugs within 6 months before enrollment or have received chemotherapy, radiotherapy, or targeted therapy within 10 mg prednisone equivalent dose per day) or other immunosuppressant systems, except for corticosteroids used for local inflammation and prevention of allergies, nausea and vomiting. Other special circumstances need to be communicated with the organizing unit. In the absence of active autoimmune diseases, inhalation or topical steroids and adrenal cortical hormone replacement therapy can be used, with an allowable dose of more than 10 mg/ day of the effective dose of prednisone treatment. 17. Patients who have receive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Turmor lesions; | — |
Countries
China
Contacts
Public ContactYong Chen
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed