An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.

What Was Tested

In this phase 3 trial, researchers set out to test Octreotide.

It had two arms (groups): Treatment group A (experimental) and Treatment group B (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 220 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Able and willing to provide a written informed consent;. 18\~75 years old,male or female;. ECOG performance status 0 or 1;. Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors (GEP-NETs) of low and medium grade (G1 or G2) confirmed by histopathology.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: there are clinical symptoms or diseases of the heart that are not well controlled;; diabetes (fasting blood glucose \> 2 × uln) that cannot be well controlled after optimal medical support treatment;; severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

The Octreotide group and the comparison group ran side by side rather than switching.

Being open-label, the Octreotide study did not mask who received what.

It started in 2023-07-06 with completion listed for 2026-12.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression-free survival (PFS) assessed by BICR (time frame: Up to 1 year follow-up).

It also tracked 5 secondary outcomes, for example Overall Survival (OS), Objective Response Rate (ORR), Duration of Overall Response (DoR), Disease Control Rate (DCR) and Incidence and severity of adverse event (AE) and serious adverse event (SAE).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 220 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.