Capecitabine Plus Toripalimab Maintenance Therapy in Metastatic Nasopharyngeal Carcinoma After First-line Treatment

This study is 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. Patients received a standard dose of toripalimab combined with gemcitabine/cisplatin every 3 weeks (Q3W) for 4-6 cycles. Efficacy was assessed after 4-6 courses of chemotherapy, and patients with PR/CR were enrolled in the clinical trial for maintenance therapy. During maintenance therapy, capecitabine and toripalimab were used as maintenance therapy every 3 weeks until toxicity was unacceptable, disease progression, consent withdrawal, or withdrawal was determined by the investigator, or a maximum of 2 years of treatment had been reached.

Inclusion criteria

• 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
• With normal liver function test (TBIL#ALT#AST ≤ 2.5×uln) (patients with liver metastasis≤5×uln)
• With normal renal function test (creatinine ≤ 1.5×uln or CCR ≥ 60ml/min)
• ECOG score is 0-1
• At least one measurable lesion according to RECIST v 1.1 (prior to gemcitabine/cisplatin plus toripalimab)
• Life expectancy is at least 12 weeks
• Patients sign informed consent forms

Exclusion criteria

• 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.
• Patients with poorly controlled or symptomatic hypercalcemia
• Pregnancy or lactation
• Malignancies other than nasopharyngeal carcinoma, with negligible risk of metastasis or death and radical outcome expected after treatment, within the 5 years prior to enrollment.
• Patients who have previously received allogeneic bone marrow transplants or solid organ transplants.
• History of autoimmune diseases
• Received systemic immunostimulant therapy (except toripalimab in palliative chemotherapy, including but not limited to interferon or IL-2) within 4 weeks prior to enrollment or during 5 half-lives of the drug.
• Receive any active vaccine within 4 weeks prior to enrollment
• Basic medical conditions that the investigator identified as likely to affect significantly drug administration and protocol adherence of the study
• Active pneumonia
• Active infections, including tuberculosis, hepatitis B, hepatitis C or HIV.
• Presence of severe neurological or psychiatric disorders, including dementia and seizures.
• Peripheral nerves which was graded as≥ 2 according to NCI-CTCAE
• Major cardiovascular diseases