This is an open label, single-arm, multi-center, phase 2 Study of SHR-1210 in recurrent/metastatic nasopharyngeal carcinoma(R/M NPC) patients who have received previous at least two lines of chemotherapy.
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with R/M NPC. The secondary objective is to observe the duration of response, progression free survival, time to response, overall survival and safety of SHR-1210 in R/M NPC. ADA is also investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
156
A humanized monoclonal immunoglobulin PD-1 antibody
Cancer Center of Sun-Yat Sen University (CCSYSU)
Guangzhou, Guangdong, China
Objective Response Rate (ORR) Assess by Independent Review Committee (IRC)
Percentage of participants achieved partial response (PR) or complete response (CR) based on IRC assessment according to the RECIST (version 1.1) is presented for this endpoint. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response .
Time frame: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death ,whichever was earlier, approximately 3 years.
ORR Assess by Investigators
Percentage of participants achieved partial response (PR) or complete response (CR) based on investigator assessment according to the RECIST (version 1.1) is presented for this endpoint. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks (28 days) after the criteria for response are first met. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response.
Time frame: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.
Duration of Response (DoR)
DoR is defined, for participants with a CR or PR per RECIST version 1.1, as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death, whichever occurs first.
Time frame: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.
Disease Control Rate (DCR)
Percentage of participants achieving PR, CR or SD (SD ≥ 8 weeks) based on IRC assessment according to the RECIST version 1.1 is presented in this endpoint. DCR is a best overall response from the time of first dose to the documented objective progression or the subsequent anti-tumor therapy (whichever occurs first).
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Time frame: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose to the date of the first documentation of PD or death, whichever occurs first. PFS was based on investigator assessment according to the RECIST version 1.1. PFS time was summarized using the Kaplan-Meier method.
Time frame: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.
Overall Survival (OS)
Overall Survival is defined as the time from the first dose to death due to any cause. OS time was measured using the Kaplan-Meier method.
Time frame: Tumor assessments were conducted at every 8 weeks from the first dose until the end of treatment, withdrawal of consent, or death (whichever was earlier), approximately 3 years.