RecruitingPhase 2NCT06505395

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

A Phase Ⅱ Randomized, Parallel-group, Open-label, Active-controlled Trial to Assess the Efficacy, Safety and Pharmacokinetics of the Long-acting Octreotide Subcutaneous Injection (SYHX2008) Versus Octreotide Microspheres (Sandostatin LAR@) in Patients With GEP-NET


Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Enrollment

90 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an octreotide injection for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) — slow-growing tumors that start in the pancreas or gut and release hormones. Octreotide mimics a natural hormone to slow tumor growth. The study assesses how effective and safe this treatment is in this patient population. **You may be eligible if...** - You are 18 or older with histologically confirmed advanced GEP-NET - Your tumor shows uptake on a somatostatin receptor scan - You have measurable disease on imaging - You have received no more than 2 prior systemic therapies - Your blood counts and organ function are adequate - You are expected to live more than 3 months **You may NOT be eligible if...** - You have received more than 2 prior systemic treatments - You have poor liver function or very abnormal blood counts - You are pregnant or not using contraception - You have serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSYHX2008 injection

The patients will accept SYHX2008 injection by subcutaneous administration every cycle.

DRUGSandostatin LAR@

The patients will accept Sandostatin LAR@ by intra-muscular administration every cycle.


Locations(1)

Chinese PLA General Hosptial

Beijing, Beijing Municipality, China

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NCT06505395