A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETs

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHTA Co., Ltd.

About this trial

The study is to evaluate the sstr antagonists, 68Ga-DOTATATE and 177Lu-DOTATATE,as a pair of diagnostic/therapeuticradiopharmaceuticals(theranostics)in patients with NETS

Eligibility criteria

Qualifiers

Ability to understand and the willingness to sign a written informed consent document;

Age ≥18 years ;

Low-and medium-grade ( G1 or G2) unresectable locally advanced or metastaticgastrointestinalneuroendocrine tumors(GEP-NETs)confirmed by histopatholog in the central laboratory,and those who had previously progressed after standard-dose somatostatin analogue(SSA)treatment;

Somatostatin receptor positive patients must be defined as all target lesions at baseline confirmed by PET/ CT examination of gallium [68Ga] dobutamine injection as somatostatin receptor positive(IRC confirmed);

Disqualifiers

Human immunodeficiency virus (HIV) antibody positive;

Hepatitis B virus (HBV) surface antigen (HBsAg) is positive and HBV-DNA is positive (≥the upper limit of detection), or hepatitis C virus (HCV) antibody (HCV-Ab) is positive and HCV-RNA is positive (≥the upper limit of detection));

Pregnant or lactating women;

Received peptide receptor radionuclide therapy (PRRT) before randomization;

Trial design

Treatments tested in this trial

  • 177Lu-DOTATATE injection
  • Octreotide LAR (Long-acting release)

Treatment groups

184 Participants
are divided into 2 treatment groups

Sponsors and collaborators