Status:
NOT_YET_RECRUITING
A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors
Lead Sponsor:
Changhai Hospital
Conditions:
Pancreatic Neuroendocrine Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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%;
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 29 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06158516
Start Date
November 30 2023
End Date
November 29 2026
Last Update
December 6 2023
Active Locations (1)
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1
Changhai Hospital
Shanghai, China, 200433