A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

Conditions
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Pancreatic Neuroendocrine Tumor

Intervention / Treatment
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* Drug: Surufatinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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%;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm A: surufatinib Arm B: placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surufatinib<br> | Drug: Surufatinib<br>* Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 2-year Overall survival | From the date of surgery to 2 years, assessed up to 24 months |