Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment … (NCT05894486) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors
China40 participantsStarted 2023-06-05
Plain-language summary
his was a single-center, single-arm phase II study evaluate the efficacy and safety of Lutetium\[177Lu\] Oxodotreotide Injection in the first-line treatment of unresectable or metastatic, progressive, G2 or G3, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Ability to understand and willingness to sign a written informed consent document.
✓. Aged 18-75 years.
✓. Histopathologically confirmed G2 or G3 unresectable locally advanced or metastatic GEP-NET, Ki67 index ≥10 and ≤ 55%. (based on the fifth edition of the WHO classification and grading criteria for neuroendocrine， tumors of the digestive system in 2019, to be centrally confirmed).
✓. Subjects have not received prior systemic antitumor therapy for the current stage of NET.
✓. Presence of at least 1 measurable site of disease (based on RECIST 1.1).
✓. All target lesions (based on RECIST 1.1) at baseline must be confirmed as growth inhibitor receptor positive by 68Ga-Dotatate PET/CT.
✓. ECOG score of 0 or 1.
✓. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 3 months of the last use of the trial drug.