Actively Recruiting
A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2024-08-26
90
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient 18 years old or older
- Histologically confirmed, advanced GEP-NET
- At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1
- Previous treatment with 2 or fewer systemic antitumor drugs
- Liver function within specified limits based on presence of liver metastasis
- Absolute neutrophil count, platelet count, hemoglobin, INR, and APTT within defined limits
- ECOG performance status of 0 to 1
- Expected survival of more than 3 months
- Able to understand the study and voluntarily sign informed consent
- Females with reproductive potential must use effective contraception during the study and for 3 months after; serum pregnancy test negative and non-lactating; males must agree to contraception during the study and for 3 months after
You will not qualify if you...
- Uncontrolled or severe diarrhea with significant dehydration
- Other malignancies diagnosed within the previous 5 years except certain skin or cervical cancers treated successfully
- Anti-tumor therapy received within 4 weeks prior to study treatment initiation or short-acting octreotide within 1 week
- Interferon, chemotherapy, transarterial chemoembolization, PRRT, radiation, or other anti-tumor treatments within specified timeframes prior to study
- Surgery (except biopsy) within 28 days before treatment or unhealed surgical incision
- Glycated hemoglobin (HbA1c) greater than 8.5%
- Symptomatic cholelithiasis without surgery
- Active brain metastases or cancerous meningitis with progression or symptoms not recovered
- Previous antitumor therapy adverse reactions not resolved to grade 1 or less unless deemed safe
- Significant uncontrolled neurological, gastrointestinal, renal, pulmonary, or other diseases
- Positive for HBV DNA, Hepatitis C antibodies with high RNA, HIV, or treponema pallidum antibodies
- Allergy to investigational drug or similar chemicals
- Severe or uncontrolled diseases including poor blood pressure control, certain heart conditions, infections, recent severe bleeding or thromboembolic events
- Other conditions unsuitable for the investigational product or affecting study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hosptial
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
J
Jianming Xu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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