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

ConditionNETS Ga68 Lu177

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

177Lu-DOTATATE injection
Drug
The eligible subjects who participate in 177Lu study are randomly assigned 1:1 to either the test group or the control group to receive treatment. Subjects in the test group are treated with 177Lu-DOTATATE injection, 7.4GBq±0.74GBq (200mCi±20mCi)/cycle, once every 8 to 12 weeks, 4 times in total.
Octreotide LAR (Long-acting release)
Drug
The eligible subjects who participate in 177Lu study are randomly assigned 1:1 to either the test group or the control group to receive treatment. Subjects in the treatment group are treated with 60mg of long-acting octreotide once every 4 weeks±3 days.

Treatment groups

184 Participants

are divided into 2 treatment groups

Group A: 177Lu-DOTATATE InjectionExperimental treatment 1 intervention

Group B: Octreotide LARActive comparator 1 intervention

Trial outcomes

Primary outcomes

Compare the 18-month PFS rate of NET patients between 177Lu-DOTATATE Injection and long-acting octreotide

Time frame

18 months from enrollment to PFS

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HTA Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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