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A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)

StatusRecruiting
PhasePhase 2
Started2024-07-30
View on ClinicalTrials.gov ↗

Amendment history

2024-08-22
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-08-01→confirmed 2024-07-30
Study sites0→1
Eligibility criteria+301 characters
[...] eptide receptor radionuclide therapy (PRRT) at any time; or received radiation therapy, anti-tumor traditional Chinese medicine treatment, hepatic artery intervention embolization, liver metastasis cryoablation or radiofrequency ablation, and other systemic anti-tumor drug treatments within 4 weeks prior to the initiation of the investigational treatment; or [...] had participated in other clinical trials within 30 days pri [...]
2024-07-16
Original filing
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.
Trial Details
NCT Number NCT06505395
Lead Sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions Gastrointestinal Neuroendocrine Pancreatic Tumor
Enrollment 90 participants
Start Date 2024-07-30
Primary Completion 2027-08-01 (estimated)
Study Completion 2028-08-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-26