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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle
Changhai Hospital
Shanghai, China
2-year disease-free survival (2y-DFS)
2-year disease-free survival (2y-DFS)
Time frame: From the date of surgery to 2 years, assessed up to 24 months
Disease-free survival time
Disease-free survival time
Time frame: 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
2-year Overall survival
Time frame: From the date of surgery to 2 years, assessed up to 24 months
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