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New treatment option for Advanced Neuroendocrine Neoplasm
Official title A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms
ClinicalTrials.gov ID: NCT06398444
What this study is testing
What is Lutetium[177Lu] Oxodotreotide Injection?
Lutetium[177Lu] Oxodotreotide Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced neuroendocrine neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, single-arm, two-part study designed to evaluate the safety and efficacy of Lutetium [177Lu] Oxyoctreotide Injection in patients with inoperable, locally advanced or metastatic, progressive, advanced somatostatin receptor (SSTR) positive neuroendocrine neoplasms (NEN) other than grade G1/G2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) and Neuroendocrine Carcinoma（NEC）.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- people who have been fully informed of this study and have voluntarily signed the Informed Consent Form (ICF).
- Age ≥12 years; people aged 12-17 years must have a body weight ≥40kg. Age eligibility must be met at the time of signing the ICF.
- Histologically confirmed, unresectable locally advanced or metastatic neuroendocrine neoplasms (NENs) [excluding well-differentiated (G1 and G2)...
- ⁶⁸Ga-Dotatate PET/CT images obtained within 24 weeks before the first drug administration are acceptable if investigators verify they can reflect the...
- Somatostatin receptor positivity is defined as lesion uptake higher than normal liver uptake;
You likely can't join if
- Serum creatinine \> 150 μmol/L (1.7 mg/dL) or creatinine clearance rate \< 50 mL/min (calculated by Cockcroft-Gault formula).
- Hemoglobin \< 100 g/L, white blood cell count \< 2.0×10⁹/L, or platelet count \< 100×10⁹/L.
- Total serum bilirubin \> 3 times the upper limit of normal (ULN).
- Serum albumin \< 30 g/L.
- Alanine transaminase (ALT) or aspartate transaminase (AST) \> 2.5×ULN.
- International Normalized Ratio (INR) \> 1.5 or activated partial thromboplastin time (APTT) \> 1.5×ULN.
See the full eligibility criteria
- people who have been fully informed of this study and have voluntarily signed the Informed Consent Form (ICF).
- Age ≥12 years; people aged 12-17 years must have a body weight ≥40kg. Age eligibility must be met at the time of signing the ICF.
- Histologically confirmed, unresectable locally advanced or metastatic neuroendocrine neoplasms (NENs) [excluding well-differentiated (G1 and G2) gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) and...
- ⁶⁸Ga-Dotatate PET/CT images obtained within 24 weeks before the first drug administration are acceptable if investigators verify they can reflect the somatostatin receptor status at enrollment;
- Somatostatin receptor positivity is defined as lesion uptake higher than normal liver uptake;
- people with any target lesion confirmed somatostatin receptor-negative by ⁶⁸Ga-Dotatate PET/CT shall be excluded. 8\. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at baseline. 9\...
- Serum creatinine \> 150 μmol/L (1.7 mg/dL) or creatinine clearance rate \< 50 mL/min (calculated by Cockcroft-Gault formula).
- Hemoglobin \< 100 g/L, white blood cell count \< 2.0×10⁹/L, or platelet count \< 100×10⁹/L.
- Total serum bilirubin \> 3 times the upper limit of normal (ULN).
- Serum albumin \< 30 g/L.
- Alanine transaminase (ALT) or aspartate transaminase (AST) \> 2.5×ULN.
- International Normalized Ratio (INR) \> 1.5 or activated partial thromboplastin time (APTT) \> 1.5×ULN.
- Positive human immunodeficiency virus (HIV) antibody.
- Positive hepatitis B surface antigen (HBsAg) combined with positive HBV-DNA (≥1×10⁴ copies/mL or confirmed positive per local study center criteria); or positive hepatitis C virus (HCV) antibody combined with positive...
- Pregnant or breastfeeding females.
- Prior history of peptide receptor radionuclide therapy (PRRT).
- people receiving short-acting octreotide who cannot discontinue it within 24 hours before and after administration of Lutetium-177 Oxotreotide Injection; or people receiving octreotide acetate microspheres who cannot...
- Received systemic anti-tumor therapies including targeted therapy, immunotherapy, anti-tumor traditional Chinese medicine therapy or chemotherapy within 4 weeks before the first study drug administration.
- Enrolled in other clinical trials and received investigational drugs within 4 weeks prior to the first dose.
- Received local anti-tumor treatments such as surgery (excluding biopsy), radical radiotherapy, hepatic arterial chemoembolization, cryoablation or radiofrequency ablation for liver metastases within 4 weeks before the...
- Received palliative radiotherapy for bone metastases within 2 weeks prior to the first dose.
- Toxicities from previous anti-tumor therapies have not recovered to Grade 1 or lower (alopecia excluded).
- Confirmed brain metastases (excluding those stabilized for at least 24 weeks before the first administration).
- Uncontrolled congestive heart failure, including baseline left ventricular ejection fraction (LVEF) \< 50%.
- Uncontrolled diabetes mellitus, including baseline fasting blood glucose \> 2×ULN.
- Presence of active infections requiring intravenous antibacterial drugs or inpatient intervention.
- History of other confirmed malignant tumors (excluding those with complete treatment and expected no recurrence within 5 years).
- Known hypersensitivity to any ingredients or excipients of Lutetium-177 Oxotreotide Injection and octreotide acetate microspheres.
- Contraindications to contrast-enhanced CT and MRI contrast agents due to allergic reactions or renal insufficiency.
- Any uncontrolled diseases, mental disorders or surgical conditions that may affect study completion (including poor treatment compliance) or make people ineligible for the investigational product.
- Based on the patient's disease characteristics, the investigator judges that alternative treatments such as chemotherapy and targeted therapy are more suitable for the patient than the study treatment, meaning the...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.