A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors

NCT06158516 | Not Yet Recruiting Phase 2

• 1 other identifier: HMPL-012-SPRING-NEN109
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 2-year Overall survival

  From the date of surgery to 2 years, assessed up to 24 months

Study Arms (2)

Surufatinib

EXPERIMENTAL

Drug: Surufatinib

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Surufatinib DRUG

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

Surufatinib

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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%;

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Adenoma, Islet Cell

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Gang Jin, Doctor

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Jianming Xu, Doctor

  Chinese PLA General Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiwei Guo, Doctor

CONTACT

+8618621500666; gestwa@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Arm A: surufatinib Arm B: placebo

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): November 29, 2026
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)