A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

Naval Military Medical University

Status and phase

Not yet enrolling

Phase 2

Conditions

Pancreatic Neuroendocrine Tumor

Treatments

Drug: Surufatinib

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06158516

HMPL-012-SPRING-NEN109

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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%;