Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasoph… (NCT04944914) | Clinical Trial Compass
RecruitingPhase 3
Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma
China188 participantsStarted 2021-06-01
Plain-language summary
We intend to compare the efficacy and safety of immunotherapy plus stereotactic body radiotherapy at oligometastatic lesions and immunotherapy alone among patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical local-regional treatment through this multicenter randomized phase 3 trial.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female; 18-70 years of age.
✓. Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled.
✓. Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect.
✓. Imageological evidence for oligometastatic lesions (metastatic tissue biopsy preferred but not necessary). The number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3.
✓. ECOG performance status of 0 or 1.
✓. Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
✓. If metastatic lesions have received local treatment (surgery, radiofrequency ablation, radiotherapy etc.):
✓. Maximum diameter of brain metastatic lesion no more than 3cm.
Exclusion criteria
✕. Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure.
✕. CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
✕. History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody.