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This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T3011 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T3011 | Biological | T3011 will be given intratumorally, Q2W; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Adverse event type, incidence, duration | 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 | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease | Approximately 2 years |
| Duration of remission (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Guo | Contact | 0086-010-88196370 | guoj307@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
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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.
| 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. | Approximately 2 years |
| Overall Survival (OS) | Determination of the overall survival time of all patients | Approximately 2 years |
| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | China |
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| Jilin Cancer Hospital | Recruiting | Changchun | China |
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| Chengdu Shangjin Nanfu Hospital | Recruiting | Chengdu | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | China |
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| The Third People's Hospital of Zhengzhou | Recruiting | Zhengzhou | China |
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| Sun Yat-sen University Cancer Center | Recruiting | Zhongshan | China |
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