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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06158516
Other study ID # HMPL-012-SPRING-NEN109
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date November 30, 2023
Est. completion date November 29, 2026

Study information

Verified date November 2023
Source Changhai Hospital
Contact Shiwei Guo, Doctor
Phone +8618621500666
Email gestwa@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 29, 2026
Est. primary completion date November 29, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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%;

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Changhai Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 2-year Overall survival 2-year Overall survival From the date of surgery to 2 years, assessed up to 24 months
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