A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06158516
• Other study ID #: HMPL-012-SPRING-NEN109
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 30, 2023
• Est. completion date: November 29, 2026

Study information

• Verified date: November 2023
• Source: Changhai Hospital
• Contact: Shiwei Guo, Doctor
• Phone: +8618621500666
• Email: gestwa[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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%;

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumor

Intervention

Drug:
• Surufatinib
Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
• Placebo
Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

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