About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Capecitabine plus toripalimab
Treatment groups
Locations
Sponsors and collaborators
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