Stereotactic Body Radiotherapy (SBRT) Combined With Chemotherapy and Tislelizumab in Metastatic Nasopharyngeal Carcinoma: A Single-arm, Phase Ⅱ Study
Radiotherapy and immunotherapy have achieved good survival benefit in advanced nasopharyngeal carcinoma. A number of clinical studies of immunotherapy combined with radiotherapy for nasopharyngeal carcinoma are also ongoing. This study preliminarily explored the efficacy and safety of SBRT combined with tislelizumab and chemotherapy in metastatic nasopharyngeal carcinoma. Hypofractionated radiotherapy combine with systemic chemotherapy and immunotherapy in advanced nasopharyngeal carcinoma. Not only it can achieve rapid response of distant metastases, but also to achieve long-term survival benefit for patients, which provides the reference for subsequent studies.
• Signed a written informed consent form (ICF) voluntarily.
• Male or female, aged from 18 to 75 years.
• Pathologically confirmed newly diagnosed or treated metastatic patients are not suitable for radiotherapy.
• Have not received treatment for metastatic nasopharyngeal carcinoma.
• At least one metastatic lesion can be treated with SBRT.
• ECOG score 0-1.
• Expected survival expectancy of no less than 6 months.
• Adequate bone marrow/liver and kidney function/heart and lung and other physiological function reserves, expected to successfully complete chemoradiotherapy and immunotherapy.
• Women of childbearing potential must confirm a negative serum pregnancy test and agree to use effective contraception during study drug use and for 150 days after the last dose.
⁃ Male patients with sexual partners of childbearing potential must agree to use effective contraception during study drug use and for 150 days after the last dose. Subject is willing and able to comply with visits, treatment regimen, laboratory tests, and other requirements of the study as specified in the schedule.
⁃ Subjects are willing and able to comply with visits, treatment regimens, laboratory tests, and other requirements of the study as spe