A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocr… (NCT06398444) | Clinical Trial Compass
RecruitingPhase 2/3
A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms
China85 participantsStarted 2024-06-11
Plain-language summary
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）.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects who have been fully informed of this study and have voluntarily signed the Informed Consent Form (ICF).
. Age ≥12 years; subjects 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) \[excluding well-differentiated (G1 and G2) gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) and neuroendocrine carcinomas (NECs)\]. The target population mainly includes:
.Have documented disease progression within 1 year prior to the first study drug administration, and have not received any other systemic anti-tumor therapy after disease progression.
.Have at least one measurable lesion at baseline per RECIST 1.1 criteria. 7. All baseline target lesions (per RECIST 1.1) must be confirmed as somatostatin receptor-positive via ⁶⁸Ga-Dotatate PET/CT.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of adverse events (AE) (Part1)
. 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;
. Subjects with any target lesion confirmed somatostatin receptor-negative by ⁶⁸Ga-Dotatate PET/CT shall be excluded.
Exclusion criteria
. 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 HCV-RNA (≥1×10³ copies/mL).