A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)

What Was Tested

This registered phase 2 trial tested Octreotide.

It had two arms (groups): SYHX2008 injection (experimental) and Octreotide Microspheres cohort (Sandostatin LAR@) (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patients will be randomized to SYHX2008 cohort or Octreotide Microspheres cohort (Sandostatin LAR@).

Who Took Part

The registry lists 90 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: Male or female patient ≥18 years old;. Histologically confirmed, advanced GEP-NET;. At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1;. Previous treatment with ≤2 systemic antitumor drugs;. ECOG performance status of 0 to 1.

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection;; surgery (except biopsy) within 28 days prior to the initiation of investigational treatment or unhealed surgical incision;; patients have symptomatic cholelithiasis or a history of symptomatic cholelithiasis at screening, but with no performed surgery treatment;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

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 2024-07-30 with completion listed for 2027-08-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC) (time frame: Up to 1 years following the last patient enrolled).

It also tracked 8 secondary outcomes, for example Overall survival (OS), PFS as assessed by local Investigators, Overall response rate(ORR), Disease control rate (DCR), Duration of response (DOR) and Time to Tomor Progression(TTP).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 90 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.