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This Phase III, multicenter, randomized, open-label, controlled study is designed to assess the efficacy and safety of ZG006 versus investigator-selected chemotherapy in participants with DLL3-positive advanced neuroendocrine carcinoma who have received prior systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | ZG006 Q2W |
|
| Control Group | Active Comparator | Investigator-selected chemotherapy (such as FOLFIRI regimen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZG006 | Biological | ZG006 will be administered as an intravenous (IV) infusion. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival（OS） | Duration from the date of initial treatment to the date of death due to any cause. | up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) (RECIST1.1) | A duration from the date of initial treatment to disease progression or death of any cause. | up to approximately 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shangdi Ning | Contact | +86-0512-57309965 | ningsd@zelgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Wu | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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| 5-fluorouracil, Calcium folinate and Irinotecan |
| Drug |
Irinotecan 180 mg/m^2, Calcium folinate 400 mg/m^2, 5-Fluorouracil: 400 mg/m^2 by intravenous infusion on Day 1; 5-Fluorouracil: 2400 mg/m^2 by continuous intravenous infusion over 46 to 48 hours， once two weeks. |
|
|
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077146 | Irinotecan |
| C480833 | IFL protocol |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
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