This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.
The patient was histologically or cytologically diagnosed with nasopharyngeal carcinoma;
The patient was newly diagnosed with metastatic nasopharyngeal carcinoma (AJCC eighth edition), and after 4-6 cycles of gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen, the efficacy reached more than stable disease;
Except for the primary tumor and cervical lymph node metastasis, less than 5 distant organ metastases, and were suitable for SBRT radiotherapy;
ECOG PS score 0-2 points;
Recurrent and metastatic nasopharyngeal carcinoma after initial treatment;
Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen), including induction chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy, surgery and other treatments;
Central nervous system metastastic (confirmed or suspected);
Allergy to PD-1 monoclonal antibody or other PD-1 monoantibody; intolerance or allergy to capecitabine; suffering any disease or extrinsic factors affecting oral drugs;
Single group
SBRT radiotherapy + Conventionally fractionated radiotherapy
RadiationRadiotherapy was performed 3-6 weeks after the end of first-line treatment, followed by conventional fractionated radiotherapy of the primary tumor and cervical lymph node metastases, SBRT radiotherapy of distant organ metastases 3-6 weeks later.
PD-1 inhibitor
DrugImmunotherapy of PD-1 inhibitor is used during the whole time of this trial until subjects were withdrawn from the trial or the trial complete
Capecitabine
DrugCapecitabine is treated for patients 3-6 weeks after radiotherapy, which combines with PD-1 inhibitor as the maintenance regimen in the trial.
Progress-free survival
The time between enrollment and progression(in any way) or death (for any reason)
Overall survival
Time from randomization to death (for any reason)
Duration of response
Time from the first evaluation of the tumor as CR or PR to the first evaluation as PD or death from any cause
Incidence of Treatment-Emergent Adverse Events
The incidence of adverse events (≥Grade 2，CTCAE V5.0)
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