A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

June 9, 2026 updated by: Guo ShiWei, Changhai Hospital

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: From the date of surgery to 2 years, assessed up to 24 months
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
Time Frame: 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
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
Time Frame: From the date of surgery to 2 years, assessed up to 24 months
2-year Overall survival
From the date of surgery to 2 years, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Actual)

June 9, 2026

Study Completion (Actual)

June 9, 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)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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