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This investigator-initiated study closed to recruitment early due to slower-than-anticipated patient accrual.
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pNENs still have a risk of recurrence after radical resection, and the overall recurrence and metastasis rate is as high as 13.7%-36.2% in China. At present, there is no standard adjuvant therapy for pNEN, and prospective studies are still lacking. This study was a randomized, double-blind, placebo-controlled, multicenter clinical trial to explore the efficacy and safety of surufatinib in the adjuvant treatment of pNET, in order to further improve the prognosis of patients and to provide high-quality research evidence for adjuvant therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surufatinib | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surufatinib | Drug | Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year disease-free survival (2y-DFS) | 2-year disease-free survival (2y-DFS) | From the date of surgery to 2 years, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival time | Disease-free survival time | From the date of surgery to the date of distant metastasis or recurrence or death due to any cause, whichever came first, assessed up to 120 months |
| 2-year Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Jin, Doctor | Changhai Hospital | Principal Investigator |
| Jianming Xu, Doctor | Chinese PLA General Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | 200433 | China |
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| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
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Arm A: surufatinib Arm B: placebo
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| Placebo | Drug | Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle |
|
2-year Overall survival
| From the date of surgery to 2 years, assessed up to 24 months |
| D010190 |
| Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |