Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Octreotide.

This trial is conducted to evaluate sirolimus for injection (albumin bound) combined with octreotide long-acting injection in patients with unresectable or recurrent GEP-NETs.

It had three arms (groups): Sirolimus combined with octreotide (experimental), Sirolimus monotherapy (experimental) and Everolimus monotherapy (active comparator).

Sirolimus for injection (albumin bound) combined with octreotide long-acting injection will be administrated on a 28-day cycle.

Sirolimus for injection (albumin bound) will be administrated on a 28-day cycle.

Everolimus (QD) will be orally administrated on a 28-day cycle. Only for Phase III.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 298 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: 1\. Unresectable locally advanced or metastatic G1/G2 GEP-NETs diagnosed by histology, according to the 2019 WHO histological grading criteria. 2\. Having poor prognostic factors. 3\. Non-functional GEP-NETs are required. 4\. At least one evaluable lesion meets the RECIST V1.1 standard (Applicable only to the phase II safety run-in stage). 6\. ECOG 0\~2.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: 2\. has uncontrolled/severe diarrhea or an axillary temperature \> 38.0°c at enrollment; 3\. received treatment with other unlisted clinical investigational drugs within 4 weeks prior to the first use of the investigational drug; 4\. undergone major surgical procedures within 4 weeks prior to the first use of the investigational drug and have not fully recovered.

How the Study Was Run

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

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

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

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-08-29 with completion listed for 2028-08-29.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Phase II: Incidences of Adeverse Events (AEs) (time frame: Up to 3 years). Phase II: Objective Response Rate (ORR） per investigator (time frame: Up to 1 year). Phase III: Progression Free Survival (PFS) per Blinded Independent Review Committee (BIRC) (time frame: Up to 3 years).

It also tracked 16 secondary outcomes, for example Phase II: Duration of Response (DOR) per investigator, Phase II: Disease Control Rate (DCR) per investigator, Phase II: Progression Free Survival (PFS) per investigator, Phase II: Overall Survival (OS), Peak Concentration：Cmax and Area under the plasma concentration-time curve: AUC.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Octreotide in 298 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.