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

What Was Tested

The trial (phase 3) is built around Octreotide.

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

It had two arms (groups): 177Lu-DOTATATE Injection (experimental) and Octreotide LAR (active comparator).

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.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 184 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to understand and the willingness to sign a written informed consent document;. Age ≥18 years ;. 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);. There is at least one measurable lesion at baseline;. BaselineECOG score 0 or 1;.

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: human immunodeficiency virus (hiv) antibody positive;; pregnant or lactating women;; received peptide receptor radionuclide therapy (prrt) before randomization;.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2023-12-12 with completion listed for 2026-11-24.

It ran at 1 site in China.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: 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).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 184 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.