A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Neuroendocrine Tumor
• Intervention / Treatment: Drug: Surufatinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shiwei Guo, Doctor; Phone Number: +8618621500666; Email: gestwa@163.com

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital
    • Contact: Shiwei Guo, Doctor; Phone Number: +8618621500666; Email: gestwa@163.com
    • Principal Investigator: Gang Jin, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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%;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Gang Jin, Doctor, Changhai Hospital; Principal Investigator: Jianming Xu, Doctor, Chinese PLA General Hosptial

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2023
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): November 29, 2026

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Diseases; Adenoma; Pancreatic Neoplasms; Neuroendocrine Tumors; Adenoma, Islet Cell
• Other Study ID Numbers: HMPL-012-SPRING-NEN109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No