SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma
ConditionNasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
Eligibility criteria
Qualifiers
Diagnosed as recurrence/metastatic NPC
Histopathological diagnosis of NPC(WHO II/III)
ECOG 0-1 point
No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
Disqualifiers
Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin;
Unexplained fever > 38.5 #, except for tumor fever;
Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
Trial design
Treatments tested in this trial
- SBRT
- Low-dose Radiotherapy (LDRT)
- Toripalimab
- Gemcitabine
- Cisplatin
- IMRT
Treatment groups
148 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov