To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Penplimab Injection: Intravenous infusion of Penplimab 200 mg Q3W, with a 3-week treatment cycle. Anlotinib Hydrochloride Capsules: 10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks. Gemcitabine injection: Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.
10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGPFS
PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause.
Time frame: Baseline up to 2 years
Objective Response Rate(ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR)
Time frame: Baseline up to 2 years
Disease Control Rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD)
Time frame: Baseline up to 2 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up
Time frame: Baseline up to 2 years
Time to Response (TTR)
TTR defined as the time from randomization to the first recorded CR or PR
Time frame: Baseline up to 2 years
Duration of Response (DOR)
DOR defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.
Time frame: Baseline up to 2 years
PD-L1 expression
Evaluating the correlation between PD-L1 expression and efficacy in tumor tissue samples.
Time frame: Tumor tissue samples must be provided to the research center prior to initial administration
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Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.
Blood EBV level
Evaluate the correlation between the copy number of EBV DNA in the blood of subjects and their efficacy.
Time frame: Baseline up to 2 years
Evaluate the health-related quality of life (HRQoL) of subjects
Evaluate the health-related quality of life (HRQoL) of subjects using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire scale。The minimum values is 1,the maximum values is 4,and whether higher scores mean a worse outcome.
Time frame: Baseline up to 2 years