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This clinical study evaluated the efficacy and safety of T3011 in combination with PD-1/PD-L1 inhibitors in subjects with advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T3011 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T3011 high dose | Biological | T3011 high dose: T3011 will be given intratumorally,Q2W; PD-1/PD-L1 inhibitor:Administered by intravenous infusion,3 mg/kg,Q2W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Adverse event type, incidence, duration | Approximately 2years |
| Objective response rate(ORR) | Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1 | Approximately 2years |
| 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 2years |
| Duration of remission (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ye Guo | Contact | 0086-021-38804518 | pattrickguo@mail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anyang Cancer Hospital | Recruiting | Anyang | China |
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| T3011 middle dose | Biological | 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 | Biological | T3011 low dose: T3011 will be given intratumorally,Q2W; PD-1/PD-L1 inhibitor:Administered by intravenous infusion,3 mg/kg,Q2W |
|
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 2years |
| Progression-free survival (PFS) | From the start date of study treatment to the date of progression disease or death , whichever occurred first. | Approximately 2years |
| Overall Survival (OS) | Determination of the overall survival time of all patients | Approximately 2years |
| The First Affiliated Hospital of Bengbu Medical University | Recruiting | Bengbu | China |
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| Hunan cancer hospital | Recruiting | Changsha | China |
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| Sichuan Cancer Hospital | Recruiting | Chengdu | China |
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| Dongguan People's Hospital | Recruiting | Dongwan | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Recruiting | Guangzhou | China |
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| The First Affiliated Hospital of Guangdong Pharmaceutical University | Recruiting | Guangzhou | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Ha’erbin | China |
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| Shandong cancer hospital | Recruiting | Jinan | China |
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| Jiangxi cancer hospital | Recruiting | Nanchang | China |
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| Guangxi Medical University Affiliated Cancer Hospital | Recruiting | Nanning | China |
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| Shanghai East Hospital | Recruiting | Shanghai | China |
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| Shanghai Ninth People's Hospital | Recruiting | Shanghai | China |
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| Liaoning Cancer Hospital | Recruiting | Shenyang | China |
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| Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center | Recruiting | Shenzhen | China |
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| Shanxi Cancer Hospital | Recruiting | Taiyuan | China |
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| Tianjin cancer hospital | Recruiting | Tianjin | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | China |
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| Henan cancer hospital | Recruiting | Zhengzhou | China |
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