Pancreatic Neuroendocrine Tumor
Conditions
Brief summary
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.
Interventions
DRUGSurufatinib
Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
DRUGPlacebo
Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Arm A: surufatinib Arm B: placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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%;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year disease-free survival (2y-DFS) | From the date of surgery to 2 years, assessed up to 24 months | 2-year disease-free survival (2y-DFS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Disease-free survival time |
| 2-year Overall survival | From the date of surgery to 2 years, assessed up to 24 months | 2-year Overall survival |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORGang Jin, Doctor
Changhai Hospital
PRINCIPAL_INVESTIGATORJianming Xu, Doctor
Chinese PLA General Hosptial
Outcome results
None listed