This clinical study evaluated the efficacy and safety of T3011 in combination with PD-1/PD-L1 inhibitors in subjects with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
T3011 high dose: T3011 will be given intratumorally,Q2W; PD-1/PD-L1 inhibitor:Administered by intravenous infusion,3 mg/kg,Q2W
T3011 middle dose: T3011 will be given intratumorally,Q2W; PD-1/PD-L1 inhibitor:Administered by intravenous infusion,3 mg/kg,Q2W
T3011 low dose: T3011 will be given intratumorally,Q2W; PD-1/PD-L1 inhibitor:Administered by intravenous infusion,3 mg/kg,Q2W
Anyang Cancer Hospital
Anyang, China
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Time frame: Approximately 2years
Objective response rate(ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1
Time frame: Approximately 2years
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Time frame: Approximately 2years
Duration of remission (DOR)
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.
Time frame: Approximately 2years
Progression-free survival (PFS)
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Time frame: Approximately 2years
Overall Survival (OS)
Determination of the overall survival time of all patients
Time frame: Approximately 2years
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