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The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutetium (177Lu) Oxodotreotide Injectionï¼›long-acting Octreotide | Drug | Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by BICR | Up to 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 5 years follow-up | |
| Objective Response Rate (ORR) | up to 1 year follow-up | |
| Duration of Overall Response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueying Zheng | Contact | +86-0518-82342973 | xueying.zheng.xz17@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 201321 | China |
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| long-acting Octreotide | Drug | High-dose long-acting Octreotide. |
|
| Up to 1 year follow-up |
| Disease Control Rate (DCR) | Up to 1 year follow-up |
| Incidence and severity of adverse event (AE) and serious adverse event (SAE) | Up to 5 years follow-up |
| Tianjin University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| ID | Term |
|---|---|
| D008187 | Lutetium |
| C000615061 | Lutetium-177 |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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