Pancreatic Neuroendocrine Tumor Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | November 29, 2026 |
Est. primary completion date | November 29, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - pNETs lesions pathologically classified as WHO grade 1/ 2/ 3; - G2/3-NET with at least one high-risk postoperative recurrence factor, including but not limited to lymph node metastasis, neurovascular invasion, pancreatic duct dilation, tumor >4cm, positive resection margin, etc.; or G1-NET with lymph node or remote transfer; - Complete surgical resection (R0 or R1 was achieved) ; - Adjuvant treatment was performed within 6-12 weeks after surgery; - Have received whole-body 68Ga PET-CT examination within the past six months; Exclusion Criteria: - Urinalysis shows urine protein = 2+ and 24-hour protein quantity test shows urinary protein =1 g; - Under anti-hypertension treatment, still uncontrolled hypertension, defined as: systolic blood pressure = 150 mmHg or diastolic blood pressure = 100 mmHg; - Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina pectoris or coronary artery bypass grafting, congestive heart failure according to the New York Heart Association (NYHA) classification = 2; ventricular arrhythmias which needs drug treatment; LVEF (LVEF) <50%; |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 2-year Overall survival | 2-year Overall survival | From the date of surgery to 2 years, assessed up to 24 months |
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