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NCT06158516TerminatedPhase 2

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

Source: ClinicalTrials.gov · Last updated 11 Jun 2026

Reason given: This investigator-initiated study closed to recruitment early due to slower-than-anticipated patient accrual.

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
6 (actual)
First submitted
28 Nov 2023
Start date
17 Jun 2024
Primary completion date
9 Jun 2026
Lead sponsor
Changhai Hospital
NCT number
NCT06158516

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Under anti-hypertension treatment, still uncontrolled hypertension, defined as: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg;

Lab values

  • 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%;

Other

  • Urinalysis shows urine protein ≥ 2+ and 24-hour protein quantity test shows urinary protein ≥1 g;

Who the study is looking for

  • 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;

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Changhai HospitalShanghaiChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.