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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Capecitabine 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
Time frame: up to 24 month
overall survival(OS)
The time is defined from the enrolment to death from any cause
Time frame: up to 24 month
Objective Response Rate(ORR)
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1
Time frame: up to 24 month
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
Time frame: up to 24 month
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
Time frame: up to 24 month
Adverse Events (AEs)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0
Time frame: up to 24 month
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