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The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Dotatate in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of GEP-NEN
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 177Lu-Dotatate PRRT | Experimental | 177Lu-Dotatate A maximum of 8 cycles of 1000mCi 177Lu-Dotatate, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 8 cycles, every 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-Dotatate PRRT | Drug | PRRT using 177Lu-Dotatate 100-150mCi will be performed 8-weekly. A maximum of 8 cycles will be administered. Other: Amino-Acid Solution The Amino-Acid Solution (AAS) to be used in this study, infused over 4-6 h, starting 30 min before PRRT |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | CT/MRI will be performed every 8 weeks for efficacy evaluation by RECIST 1.1 and CHOI | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Incidence of Treatment-related Adverse Events(Safety and Tolerability) | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause | baseline, every 8 weeks up to 1 year after last patient first treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D009380 | Neoplasms, Nerve Tissue |