A Study of Surufatinib as Adjuvant Therapy for Pancreatic Neuroendocrine Tumors
NCT06158516 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2023-12-06
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
Interventions
- DRUG
-
Surufatinib
Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
- DRUG
-
Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle
Sponsors & Collaborators
-
Changhai Hospital
lead OTHER
Principal Investigators
-
Gang Jin, Doctor · Changhai Hospital
-
Jianming Xu, Doctor · Chinese PLA General Hosptial
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-30
- Primary Completion
- 2026-11-29
- Completion
- 2026-11-29
Countries
- China
Study Locations
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