to evaluate the efficacy and safety of toripalimab and capecitabine maintenance therapy in patients with metastatic nasopharyngeal carcinoma (NPC) after first-line gemcitabine/cisplatin combined with toripalimab.
Histology confirmed metastatic nasopharyngeal carcinoma following radical treatment（Stage IVb, AJCC/UICC 8th，any T，any N，M1）
Patients receiving gemcitabine/cisplatin in combination with terriprizumab received complete response (CR) or partial response (PR) after 4-6 cycles of imaging studies
Age ≥18 years and ≤65 years
WBC≥4×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90g/L and Albumin≥28 g/L
History of severe anaphylaxis to any component of capecitabine or toripalimab
Active or untreated central nervous system metastases
Patient with necrotic lesions and judged by the investigator to be at risk of excessive bleeding
Patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage. Patients with indwelled catheters are allowed to participate.
Single group
Capecitabine plus toripalimab
DrugCapecitabine tablet: 650mg/m2, orally, twice a day, d1-d21, every 3 weeks Toripalimab: 240mg, intravenous drip, d1, every 3 weeks
progression-free survival(PFS)
The time is defined from the enrolment to progression or death from any cause
overall survival(OS)
The time is defined from the enrolment to death from any cause
Objective Response Rate(ORR)
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1
Disease Control Rate (DCR)
The proportion of patients who have achieved complete response，partial response and Stable disease assessed by investigators according to Recist v 1.1
Duration of Response (DoR)
The time is defined from first documented objective response to radiographic disease progression or death, whichever occurred first, assessed by investigator
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Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Hunan Cancer Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
