NCT05431764 Whole-target Consolidation Therapy Under Systemic Therapy for Oligometastatic Nasopharyngeal Carcinoma
| NCT ID | NCT05431764 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2022-06-20 |
| Primary Completion | 2025-06-20 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female; 18-70 years of age. 2. Had histopathologically confirmed nonkeratinizing metastatic NPC that was diagnosed as stage IVb NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary). 3. Patients who had not received anti-tumor therapy for nasopharyngeal cancer before this clinical trial. 4. 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). 5. Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT. 6. ECOG performance status of 0 or 1. 7. Maximum diameter of brain metastatic lesion no more than 3cm. 8. Maximum diameter of metastatic lesion (brain excluded) no more than 5cm. * Maximum diameter of bone metastatic