This is an open label, single-arm, multi-center, phase II study of SHR-1701 in patients with recurrent/metastatic SCCHN
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Tumor Hospital of the Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGObjective Response Rate (ORR) per RECIST 1.1
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 2 years
DOR
Duration of response
Time frame: 24 months
DCR
Disease Control Rate
Time frame: 24 months
PFS
Progression free survival
Time frame: 24 months
OS
Overall Survival
Time frame: 24 months
AEs
Incidence and severity of adverse events
Time frame: 24 months
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