A Study Of Surufatinib As Adjuvant Therapy For Pancreatic Neuroendocrine Tumors

Study Overview

A Study 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.

N/A

Pancreatic Neuroendocrine Tumor

DRUG: Surufatinib
DRUG: Placebo

HMPL-012-SPRING-NEN109

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-11-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-11-28
First Submitted that Met QC Criteria 2023-11-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-12-06
First Posted (ACTUAL) 2023-12-06	Results First Posted N/A	Last Verified 2023-11

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Surufatinib	DRUG: Surufatinib Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
PLACEBO_COMPARATOR: Placebo	DRUG: Placebo Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Surufatinib

DRUG: Surufatinib

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

PLACEBO_COMPARATOR: Placebo

DRUG: Placebo

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

Primary Outcome Measures	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	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

Contacts and Locations

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

Study Contact

Name: Shiwei Guo, Doctor

Phone Number: +8618621500666

Email: gestwa@163.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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;

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%;

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Gang Jin, Doctor, Changhai Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record