Recurrent or Metastatic Nasopharyngeal Carcinom Clinical Trial
Official title:
Phase II Study of Nivolumab Plus Gemcitabine in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma-HN17-11
NPC is a highly chemo-sensitive cancer. Platinum-containing doublet chemotherapy is regarded as the standard treatment for patients with recurrent or metastatic NPC, even though it has never been directly compared with supportive care. Until now, no randomized trials have defined the optimum regimens. At present, cisplatin plus continuous intravenous infusion of fluorouracil is widely used in patients with recurrent or metastatic nasopharyngeal carcinoma, with a response rate of 40-65%. Gemcitabine single is active and tolerable agent for recurred or metastatic NPC. Response rate (RR) was 34% and progression-free survival (PFS) was 5.0 months . Moreover, gemcitabine reduces the frequency of CD11b+GR1+ myeloid suppressor cells. Gemcitabine-induced apoptosis of established tumours may enhance the dendritic cell dependent cross-presentation of tumor antigens to T cells. Gemcitabine can function in synergy with CD40 stimulation of T cells. Hence, theoretically gemcitabine can have synergistic effect with PD-1/PD-L1 blocking agent. Immunotherapy with immune checkpoint inhibitors has gradually emerged as a promising treatment modality for head and necks squamous cell carcinoma and NPC.
Based on these evidences which suggest a function for PD-1/PD-L1 in NPC and potential synergistic effect with gemcitabine, the use of nivolumab in recurred/metastatic NPC is reasonable and valuable. So we design this phase II study of nivolumab and gemcitabine in recurred/metastatic NPC which is common cancer in Asian. ;