Assessing a new injection for treating advanced gastrointestinal neuroendocrine tumors

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

This study is testing a new injection called SYHX2008 to see if it works better than the standard treatment for adults with advanced gastrointestinal neuroendocrine tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06505395 on ClinicalTrials.gov

What this trial studies

This Phase II, open-label randomized study aims to evaluate the pharmacokinetics, efficacy, and safety of SYHX2008 compared to Octreotide Microspheres (Sandostatin LAR@) in adult patients with well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NET). Participants will be randomly assigned to receive either SYHX2008 or the standard treatment, allowing for a direct comparison of outcomes. The study will include patients with measurable, somatostatin receptor-positive lesions and will assess various health parameters to ensure participant safety and treatment effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced GEP-NET and specific health criteria.

Not a fit: Patients with liver metastasis exceeding certain enzyme levels or those with poor performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced GEP-NET.

How similar studies have performed: Other studies have shown promise in treating GEP-NET with similar pharmacological approaches, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Male or female patient ≥18 years old;
2. Histologically confirmed, advanced GEP-NET;
3. At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1;
4. Previous treatment with ≤2 systemic antitumor drugs;
5. Patients who do not have liver metastasis, with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and alkaline phosphatase (ALP) levels ≤ 2.5 times the upper limit of normal (ULN) ; and who do have liver metastasis, with ALT and AST ≤ 5 times ULN; Serum total bilirubin \<1.5 times the ULN; absolute neutrophil count (ANC) of ≥1.5×10\^9/L, platelet count of ≥90×10\^9/L, and hemoglobin ≥9 g/dL; or International Normalized Ratio (INR) ≤1.5 ULN and activated partial thromboplastin time (APTT) ≤1.5 ULN;
6. ECOG performance status of 0 to 1
7. Have expected survival of more than 3 months;
8. Adequately understand the study and voluntarily sign the Informed Consent Form;
9. Females patients with reproductive potential must agree to use an effective contraceptive method, for example, intrauterine devices, birth control medicine or condoms, during the study and within 3 months after study treatment discontinuation; or serum pregnancy tests negative and must be non-lactating participants; or males should agree contraception during the study and for within 3 months after study treatment discontinuation.

Exclusion Criteria:

1. Uncontrolled or severe diarrhea with significant dehydration;
2. Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection;
3. Anti-tumor therapy received within 4 weeks prior to the initiation of the investigational treatment, for example mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase inhibitors (TKI); or short-acting octreotide acetate was received subcutaneously or intravenously within 1 weeks prior to the initiation of the investigational treatment;
4. Interferon was received within 4 weeks prior to the initiation of the investigational treatment; or chemotherapy was received within 4 weeks prior to the initiation of the investigational treatment; or transarterial chemoembolization was received within 12 months prior to screening; or previously received peptide 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 prior to screening
5. Surgery (except biopsy) within 28 days prior to the initiation of investigational treatment or unhealed surgical incision;
6. Glycated hemoglobin (HbA1c) \> 8.5%;
7. Patients have symptomatic cholelithiasis or a history of symptomatic cholelithiasis at screening, but with no performed surgery treatment;
8. Patients with active brain metastases or cancerous meningitis meet any of the following criteria: a) Patients with prior brain metastases, imaging within 4 weeks prior to the first use of investigational drug show progression of the original lesion, or new brain metastases; b) Clinical symptoms associated with central nervous system metastasis did not recovery to baseline; c) Use cortisols, radiotherapy and other drugs to control the symptoms of central nervous system metastasis within 4 weeks before the first use of the investigational drug;
9. The adverse reactions of previous antitumor therapy have not returned to ≤ grade 1 according to CTCAE V5.0 (except that the investigators evaluate no safety risk, such as hair loss, grade 2 peripheral neuropathy or dysfunction);
10. Any clinically significant uncontrolled neurological, gastrointestinal, renal (serum creatinine \> 1.5 ULN), pulmonary, or other significant disease requiring exclusion assessed in the opinion of the Investigator;
11. Patients had hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10\^4/ml or ≥2000 IU/ml); known Hepatitis C antibodies positive and HCV RNA higher than the lower detection limit ; or human immunodeficiency virus (HIV) positive, treponema pallidum antibody positive;.
12. A history of allergy to any excipient of the investigational drug or any similar chemical structure to the investigational drug;
13. Patients had any severe or uncontrolled disease, including: 1) poor blood pressure control (systolic ≥160 mmHg or diastolic ≥100 mmHg);2) grade I or higher myocardial ischemia or myocardial infarction, symptomatic or poorly controlled arrhythmia, or congenital long QT syndrome (including QTcF ≥450ms for males, QTcF ≥470ms for females), or ≥ Grade 2 congestive heart failure \[NYHA classification\]; 3) serious infections that are not under control (oral or intravenous systemic anti-infection therapy is required for 2 weeks before the first use of the investigational drug, except for uncomplicated urinary tract infections and upper respiratory tract infections);4) previous or current severe bleeding (\>30ml of bleeding within 3 months), hemoptysis (\>5ml of fresh blood within 4 weeks), or thromboembolic events (including transient ischemic attacks) within 12 months;
14. Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions are inappropriate for the use of the investigational product or affect interpretation of study results.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hosptial — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Information Group officer

Conditions Gastrointestinal Neuroendocrine Pancreatic Tumor