A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

Phase 2

Not yet recruiting

• Conditions: Pancreatic Neuroendocrine Tumor
• Interventions: Drug: Placebo; Drug: Surufatinib

• Registration Number: NCT06158516
• Lead Sponsor: Changhai Hospital

Brief 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 effica...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Study Start: 2023-11-30
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Primary Completion: 2026-11-29
• Study Completion: 2026-11-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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;

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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%;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Surufatinib	Surufatinib	-

Primary Outcome Measures

Name	Time	Method
2-year disease-free survival (2y-DFS)	From the date of surgery to 2 years, assessed up to 24 months	2-year disease-free survival (2y-DFS)

Secondary Outcome Measures

Name	Time	Method
2-year Overall survival	From the date of surgery to 2 years, assessed up to 24 months	2-year Overall survival
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	Disease-free survival time

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, China