A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

Launched by CHANGHAI HOSPITAL · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called surufatinib to see if it can help prevent pancreatic neuroendocrine tumors (pNETs) from coming back after surgery. pNETs are a type of tumor found in the pancreas, and even after they are surgically removed, there is still a significant risk that they may return. This trial aims to test the effectiveness and safety of surufatinib as an additional treatment given after surgery, which could improve the chances of staying cancer-free.

To participate, you must have had a complete surgical removal of your pNET and be within a certain age range. You would also need to have specific risk factors that could indicate a higher chance of the tumor returning. The trial is not yet recruiting participants, but if you qualify, you can expect to be part of a study that will help gather important information about this potential treatment. It’s important to note that participants will be randomly assigned to receive either surufatinib or a placebo (a pill with no active medication) to compare the results. This research aims to provide better treatment options for patients in the future.

Gender

ALL

Eligibility criteria

• 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%;