Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors
Sirolimus for injection (albumin bound)Octreotide long-acting injectionEverolimus
Sirolimus for injection (albumin bound): Sirolimus for injection (albumin bound), ivgtt.
Octreotide long-acting injection: SC
Everolimus: Oral, once a day
Study 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. 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Primary outcome measure(s)
Phase II: Incidences of Adeverse Events (AEs) — Up to 3 years
Phase II: Dose Limiting Toxicity (DLT) — Up to 1 year
Phase II: Recommended Phase 3 Dose (RP3D) — Up to 1 year
Phase II: Objective Response Rate (ORR) per investigator — Up to 1 year
Phase III: Progression Free Survival (PFS) per Blinded Independent Review Committee (BIRC) — Up to 3 years
Trial sites (1)
Facility
City
Region
Status
Chinese PLA General Hospital
Beijing
Beijing Municipality
Recruiting
More CSPC ZhongQi Pharmaceutical Technology Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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