This study was a multicenter, open-label, phase IIb, randomized controlled trial that enrolled patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who had progressed during or after at least second-line systemic chemotherapy and PD-1/PD-L1 inhibitor therapy, or who were intolerant to such treatments. The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice guidelines. The study was approved by the ethics committees of the Sun Yat-sen University Cancer Center and other participating centers, and all patients provided written informed consent. The trial was registered with clinicaltrials.gov (NCT05126719).
The key inclusion criteria were: age 18-75 years; histologically or cytologically confirmed recurrent or metastatic NPC that is not amenable to surgery or radiotherapy; prior receipt of at least two lines of systemic chemotherapy (including platinum-based regimens, gemcitabine, taxanes/capacitabine) and failure of PD-1/PD-L1 inhibitor therapy; presence of measurable disease according to RECIST 1.1 criteria; and an ECOG performance status of 0-1. The key exclusion criteria were: peripheral neuropathy ≥ grade 2 according to CTCAE 5.0; anticipated need for surgery or other systemic/local anti-tumor therapy during the study period; and known active central nervous system metastases and/or leptomeningeal metastases. The detailed inclusion and exclusion criteria were provided in the protocol.
