Whole-target Consolidation Therapy After Standard Chemotherapy for Initial Diagnosed Distant Metastatic Nasopharyngeal Carcinoma Under Full-course Immunotherapy: An Open-Label, Single Center, Nonrandomized, Phase 2 Study
In this exploratory clinical trial, patients with newly diagnosed distant metastatic nasopharyngeal carcinoma were treated with gemcitabine+ cisplatin+PD-1 inhibitor regimen followed by whole-target radiotherapy (IMRT for local regional lesion, SBRT for distant metastasis) and PD-1 inhibitor long-term maintenance regimen. To investigate the efficacy and safety of whole target radiotherapy combined with immuno-maintenance therapy.
• Male or female; 18-70 years of age.
• Had histopathologically confirmed nonkeratinizing metastatic NPC that was diagnosed as stage IVb NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary).
• Patients who had not received anti-tumor therapy for nasopharyngeal cancer before this clinical trial.
• Patients evaluated to have a partial response (PR) or stable disease (SD) by head and neck MRI and PET/CT after 3 months of locoregional radiotherapy, and the metastatic lesions were assessed as oligometastatic lesions (the number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3).
• Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
• ECOG performance status of 0 or 1.
• Maximum diameter of brain metastatic lesion no more than 3cm.
• Maximum diameter of metastatic lesion (brain excluded) no more than 5cm.
⁃ Maximum diameter of bone metastatic lesion no more than 6cm if attending doctor decides it is safe to apply the treatment.
• Life expectancy more than 6 months.