About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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;
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Lutetium[177Lu] Oxodotreotide Injection
DrugParticipants will receive 7.4GBq (200mCi) Lutetium\[177Lu\] Oxodotreotide Injection every 8 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Incidence and severity of adverse events (AE) (Part1)
Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (Part 2)
Secondary outcomes
Overall Response Rate (ORR) (Part 1)
Progression-free survival (PFS) (Part 1)
Disease Control Rate (DCR) (Part 1)
Duration of Overall Response (DoR) (Part 1)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.