Clinical trial NCT06158516: A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pancreatic Neuroendocrine Tumor
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm A: surufatinib Arm B: placebo
Primary purpose: TREATMENT

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 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.


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%;

Primary outcomes:
measure: 2-year disease-free survival (2y-DFS)
timeFrame: From the date of surgery to 2 years, assessed up to 24 months
Secondary outcomes:
measure: Disease-free survival time
timeFrame: 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
measure: 2-year Overall survival
timeFrame: From the date of surgery to 2 years, assessed up to 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Gang Jin, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hosptial
name: Jianming Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: