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A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

NCT ID: NCT06158516

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2026-11-29

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Neuroendocrine Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm A: surufatinib Arm B: placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Surufatinib

Group Type EXPERIMENTAL

Surufatinib

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Surufatinib

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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%;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guo ShiWei

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gang Jin, Doctor

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Jianming Xu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hosptial

Locations

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Changhai Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Shiwei Guo, Doctor

Role: CONTACT

Phone: +8618621500666

Email: [email protected]

Facility Contacts

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Shiwei Guo, Doctor

Role: primary

Other Identifiers

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HMPL-012-SPRING-NEN109

Identifier Type: -

Identifier Source: org_study_id