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
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- 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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changhai Hospital | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.