This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
T3011 will be given intratumorally, Q2W;
Beijing Cancer Hospital
Beijing, China
RECRUITINGThe First Affiliated Hospital of Bengbu Medical College
Bengbu, China
RECRUITINGJilin Cancer Hospital
Changchun, China
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Time frame: Approximately 2 years
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 2 years
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 2 years
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 2 years
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 2 years
Overall Survival (OS)
Determination of the overall survival time of all patients
Time frame: Approximately 2 years
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Chengdu Shangjin Nanfu Hospital
Chengdu, China
RECRUITINGFujian Cancer Hospital
Fuzhou, China
RECRUITINGThe Third People's Hospital of Zhengzhou
Zhengzhou, China
RECRUITINGSun Yat-sen University Cancer Center
Zhongshan, China
RECRUITING