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

CSPC Pharmaceutical Group

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Gastroenteropancreatic Neuroendocrine Tumors

Treatments: Drug: Everolimus; Drug: Octreotide long-acting injection; Drug: Sirolimus for injection (albumin bound)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07165886

HB1901-010

Details and patient eligibility

About

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 was conducted to evaluate sirolimus for injection (albumin bound) combined with octreotide long-acting injection in patients with unresectable or recurrent GEP-NETs in the first-line setting.

Enrollment: 243 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Unresectable locally advanced or metastatic G1/G2 GEP-NETs diagnosed by histology, according to the 2019 WHO histological grading criteria.
• 2. Have not received systemic anti-tumor treatment for neuroendocrine tumors in the past.
• 3. Having poor prognostic factors.
• 4. Non-functional GEP-NETs are required.
• 5. At least one measurable lesion that meets the RECIST V1.1 standard.
• 6. ECOG 0~2.
• 7. Organ function reserve is good.
• 8. Be able to sign a written informed consent form.

Exclusion criteria

• 1. Received treatment with other unlisted clinical investigational drugs within 4 weeks prior to the first use of the investigational drug.
• 2. Undergone major surgical procedures within 4 weeks prior to the first use of the investigational drug and have not fully recovered.
• 3. Received systemic use of corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first use of the study drug.
• 4. With an infection that requires systemic anti-infective treatment within 2 weeks prior to the first use of the study drug.
• 5. 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.
• 6. Has a serious history of cardiovascular and cerebrovascular diseases.
• 7. Having active brain metastasis and/or malignant meningitis.
• 8. With a history of severe lung diseases.
• 9. During screening, there may be symptomatic gallstones or a history of symptomatic gallstones but no surgical treatment has been performed.
• 10. Abnormal thyroid function during screening.
• 11. Known to have hypersensitivity reactions or intolerance to any component of all investigational drugs or their excipients.
• 12. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.
• 13. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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243 participants in 3 patient groups

Sirolimus combined with octreotide

Experimental group

Description:

Sirolimus for injection (albumin bound) combined with octreotide long-acting injection (Q2W) will be administrated on a 28-day cycle

Treatment:

Drug: Sirolimus for injection (albumin bound)

Drug: Octreotide long-acting injection

Sirolimus monotherapy

Experimental group

Description:

Sirolimus for injection (albumin bound) (Q2W) will be administrated on a 28-day cycle.

Treatment:

Drug: Sirolimus for injection (albumin bound)

Everolimus monotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Everolimus