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The purpose of this study is to evaluate the retention in tumour and distribution behavior of [Lu-177]-Catalase after intratumoral injection,and preliminary evaluation the efficacy and safety of [Lu-177]-Catalase.
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At day1, patients who meet the eligibility requirements will be intratumoral injection the [Lu-177]-Catalase.The efficacy evaluation will be conducted at one month p.i., whether to continue intratumoral injection the [Lu-177]-Catalase, depending on the patient's efficacy and safety results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [ Lu-177]-Catalase | Experimental | Participants received [ Lu-177]-Catalase intratumoral injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [ Lu-177]-Catalase | Drug | [ 177Lu]-Catalase is administered by intratumoral puncture every four weeks, and the specific dose is related to the size of the tumor |
|
| Measure | Description | Time Frame |
|---|---|---|
| The absorbed radiation dose of tumor and normal organs | Calculation of effective absorbed dose of tumor in situ injection | From first dose of study drug through 8 weeks post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary efficacy of [ Lu-177]-Catalase based on tumor response | Tumor volume based on RECIST 1.1. | From first dose of study drug through 8 weeks post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events for [ Lu-177]-Catalase | Occurrence of adverse events for [ Lu-177]-Catalase | From first dose of [ Lu-177]-Catalase through 8 weeks post dose. |
Inclusion Criteria:
The Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhi Yang | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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