A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)
NCT06505395 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2024-08-26
Summary
The purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET.
Conditions
- Gastrointestinal Neuroendocrine Pancreatic Tumor
Interventions
- DRUG
-
SYHX2008 injection
The patients will accept SYHX2008 injection by subcutaneous administration every cycle.
- DRUG
-
Sandostatin LAR@
The patients will accept Sandostatin LAR@ by intra-muscular administration every cycle.
Sponsors & Collaborators
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jianming Xu, M.D · The First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-30
- Primary Completion
- 2027-08-01
- Completion
- 2028-08-01
Countries
- China
Study Locations
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