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Gastroenteropancreatic Neuroendocrine TumorsPhase 2/3NCT07165886

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

A Phase 2/3 study testing Sirolimus for injection (albumin bound), Octreotide long-acting injection and Everolimus in people with Gastroenteropancreatic Neuroendocrine Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

There is limited evidence regarding the benefit of adding somatostatin analogs to molecular targeted agents for well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with poor prognostic factors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sirolimus for injection (albumin bound), Octreotide long-acting injection and Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
1 siteChina
Study dates
29 Aug 2025to 29 Aug 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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.
  • 7. Organ function reserve is good.
  • 8. Be able to sign a written informed consent form.

Who cannot join

  • 1. Patients who have previously received SSTR-targeted therapies (including somatostatin analogs [SSAs] and peptide receptor radionuclide therapy) and/or mTOR inhibitors (Patients who received SSAs in the adjuvant setting and experienced recurrence ≥6 months after treatment completion may be enrolled)[ Applicable to Phase II dose expansion and Phase III stages].
  • 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.
  • 5. Received systemic use of corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first use of the study drug.
  • 6. With an infection that requires systemic anti-infective treatment within 2 weeks prior to the first use of the study drug.
Show all 15Show fewer
  • 7. Those who have used strong inhibitors or inducers of CYP3A4 liver metabolic enzymes within 2 weeks prior to the first use of the investigational drug or still need to continue using such drugs.
  • 8. Has a serious history of cardiovascular and cerebrovascular diseases.
  • 9. Having active brain metastasis and/or malignant meningitis.
  • 10. With a history of severe lung diseases.
  • 11. During screening, there may be symptomatic gallstones or a history of symptomatic gallstones but no surgical treatment has been performed.
  • 12. Abnormal thyroid function during screening.
  • 13. Known to have hypersensitivity reactions or intolerance to any component of all investigational drugs or their excipients.
  • 14. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.
  • 15. History of autoimmune diseases (excluding tuberous sclerosis), history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

    Recruiting

Other trials in China

About this study

Official title: Phase II/III Study to Evaluate the Safety and Efficacy of Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

There is limited evidence regarding the benefit of adding somatostatin analogs to molecular targeted agents for well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with poor prognostic factors. 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.

Being tested
Sirolimus for injection (albumin bound), Octreotide long-acting injection, Everolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sirolimus for injection (albumin bound)Drug

    Sirolimus for injection (albumin bound), ivgtt.

  • Octreotide long-acting injectionDrug

    SC

  • EverolimusDrug

    Oral, once a day

Study groups in NCT07165886
Study groupRoleWhat they receive
Sirolimus combined with octreotideExperimentalSirolimus for injection (albumin bound) combined with octreotide long-acting injection will be administrated on a 28-day cycle
Receives: Drug: Sirolimus for injection (albumin bound); Drug: Octreotide long-acting injection
Sirolimus monotherapyExperimentalSirolimus for injection (albumin bound) will be administrated on a 28-day cycle.
Receives: Drug: Sirolimus for injection (albumin bound)
Everolimus monotherapyActive comparatorEverolimus (QD) will be orally administrated on a 28-day cycle. Only for Phase III
Receives: Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase II: Incidences of Adeverse Events (AEs)

    Measured: Up to 3 years

  2. Phase II: Dose Limiting Toxicity (DLT)

    Measured: Up to 1 year

  3. Phase II: Recommended Phase 3 Dose (RP3D)

    Measured: Up to 1 year

  4. Phase II: Objective Response Rate (ORR） per investigator

    Measured: Up to 1 year

  5. Phase III: Progression Free Survival (PFS) per Blinded Independent Review Committee (BIRC)

    Measured: Up to 3 years

Secondary outcomes (16)

  1. Phase II: Duration of Response (DOR) per investigator

    Measured: Up to 3 years

  2. Phase II: Disease Control Rate (DCR) per investigator

    Measured: Up to 3 years

  3. Phase II: Progression Free Survival (PFS) per investigator

    Measured: Up to 3 years

  4. Phase II: Overall Survival (OS)

    Measured: Up to 3 years

  5. Peak Concentration：Cmax

    Measured: Up to 3 years

  6. Area under the plasma concentration-time curve: AUC

    Measured: Up to 3 years

  7. Half-Life: t1/2

    Measured: Up to 3 years

  8. Phase II: Blood concentrations and PK parameters of sirolimus for injection(albumin bound) and Octreotide long-acting injection.

    Measured: From first dose of treatment to C3D15

  9. Phase II: Changes in serum chromogranin A, 24-hour urinary 5-hydroxyindoleacetic acid, and serum IGF-1 levels from baseline.

    Measured: From first dose of treatment to end of treatment

  10. Phase III: Progression Free Survival (PFS) per investigator

    Measured: Up to 3 years

  11. Phase III: Objective Response Rate (ORR）

    Measured: Up to 3 years

  12. Phase III: Duration of Response (DOR)

    Measured: Up to 3 years

  13. Phase III: Disease Control Rate (DCR)

    Measured: Up to 3 years

  14. Phase III: Incidences of Adeverse Events (AEs)

    Measured: Up to 3 years

  15. Phase III: Overall Survival (OS)

    Measured: Up to 3 years

  16. Phase III: Changes in serum chromogranin A, 24-hour urinary 5-hydroxyindoleacetic acid, and serum IGF-1 levels from baseline.

    Measured: From first dose of treatment to end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start29 Aug 2025
  3. Primary completion29 Aug 2028 (estimated)
  4. Study completion29 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
298 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07165886
Sponsor's protocol ID
HB1901-010
Status last verified
Apr 2026
First submitted
3 Sep 2025
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sirolimus for injection (albumin bound), Octreotide long-acting injection and Everolimus in people with Gastroenteropancreatic Neuroendocrine Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase II: Incidences of Adeverse Events (AEs) (time frame: Up to 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07165886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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