This is an open label, multi-center, phase I/II study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Cancer Hospital of Guangzhou Sun Yat-sen University
Guangzhou, Guangdong, China
ORR
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Time frame: up to approximately 2 years (anticipated)
DoR
Duration of Response per RECIST 1.1
Time frame: up to approximately 2 years (anticipated)
DCR
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
Time frame: up to approximately 2 years (anticipated)
PFS
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Time frame: up to approximately 2 years (anticipated)
OS
Overall Survival is defined as the time from registration to death due to any cause, or censored at date last known alive. OS will be measured by the Method of Kaplan and Meier.
Time frame: up to approximately 2 years (anticipated)
AEs
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: up to approximately 2 years (anticipated)
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