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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.
Full description
This exploratory clinical trial will evaluate tumor control rate, survival, and safety of newly diagnosed distant metastatic nasopharyngeal carcinoma by further adding local regional IMRT, distant metastatic SBRT and immuno-maintenance therapy to the standard regimen of gemcitabine+ cisplatin+ PD-1 inhibitor (historical data). To explore whether the "full target" model can be a better comprehensive therapy for the initial diagnosed distant metastatic nasopharyngeal carcinoma in the era of immunotherapy.
Enrollment
Sex
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Volunteers
Inclusion criteria
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.
Life expectancy more than 6 months.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
38 participants in 1 patient group
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Central trial contact
Ming-Yuan Chen, MD, PhD; Rui You, MD, PhD
Data sourced from clinicaltrials.gov
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