A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorSinotau Pharmaceutical Group

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

Qualifiers

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

Treatments tested in this trial

  • Lutetium[177Lu] Oxodotreotide Injection

Treatment groups

85 Participants
are divided into 1 treatment group

Sponsors and collaborators