Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma: A Multicenter, Open-Label, Phase II Trial (NPC-CR01)
The purpose of this study is to explore the efficacy and tolerance of local consolidative radiotherapy combined with Camrelizumab and chemotherapy in patients with oligometastatic nasopharyngeal carcinoma
• 1\. 18-70 years old, no gender limit;
• 2\. Oligo metastasis is defined as less than or equal to 5 metastatic lesions and less than or equal to 2 metastatic organs
• 3\. Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months;
• 4\. Has good organ function:
‣ Hematology: WBC\>3.0×109/L; ANC\>1.5×109/L; Hb\>90g/L; PLT\>100×109/L; Albumin ≥3g/dL;
⁃ Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert disease and serum bilirubin level ≤ 3 times ULN can be included), AST and ALT ≤ 3 times ULN (if liver metastases occur , Then AST/ALT≤5 times ULN), and alkaline phosphatase≤3 times ULN (if liver or bone metastasis occurs, ALP≤5 times ULN); （3） Coagulation function: International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; （4）Renal function: According to the Cockcroft-Gault formula (Appendix 8), serum creatinine ≤1.5 times ULN or creatinine clearance ≥60mL/min.
• 5\. Female subjects have a negative pregnancy test (for female patients with fertility); female patients without fertility;
• 6\. Male patients with fertility and female patients with fertility and risk of pregnancy must agree to take adequate contraceptive measures throughout the study period, and contraception lasts for 12 months after receiving this program.
• 7\. Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests and other research procedures;
• 8\. During the research period, they are willing to comply with the arrangement and cannot participate in any other clinical research on drugs and medical devices;
• 9\. For patients who have previously received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or radiotherapy for non-metastatic diseases, the time from the last chemotherapy and/or radiotherapy to randomization must reach a non-treatment interval of ≥ 6 months . Oral S1 and capecitabine have no requirement for treatment interval for those who are progressing during chemotherapy.
• 10\. The patients sign a formal informed consent form to show that they understand that this study complies with the hospital's policies