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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
298
Sirolimus for injection (albumin bound), ivgtt.
Oral, once a day
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGPhase II: Incidences of Adeverse Events (AEs)
Time frame: Up to 3 years
Phase II: Dose Limiting Toxicity (DLT)
Time frame: Up to 1 year
Phase II: Recommended Phase 3 Dose (RP3D)
Time frame: Up to 1 year
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
Phase II: Duration of Response (DOR) per investigator
Time frame: Up to 3 years
Phase II: Disease Control Rate (DCR) per investigator
Time frame: Up to 3 years
Phase II: Progression Free Survival (PFS) per investigator
Time frame: Up to 3 years
Phase II: Overall Survival (OS)
Time frame: Up to 3 years
Peak Concentration:Cmax
Time frame: Up to 3 years
Area under the plasma concentration-time curve: AUC
Time frame: Up to 3 years
Half-Life: t1/2
Time frame: Up to 3 years
Phase II: Blood concentrations and PK parameters of sirolimus for injection(albumin bound) and Octreotide long-acting injection.
Time frame: From first dose of treatment to C3D15
Phase II: Changes in serum chromogranin A, 24-hour urinary 5-hydroxyindoleacetic acid, and serum IGF-1 levels from baseline.
Time frame: From first dose of treatment to end of treatment
Phase III: Progression Free Survival (PFS) per investigator
Time frame: Up to 3 years
Phase III: Objective Response Rate (ORR)
Time frame: Up to 3 years
Phase III: Duration of Response (DOR)
Time frame: Up to 3 years
Phase III: Disease Control Rate (DCR)
Time frame: Up to 3 years
Phase III: Incidences of Adeverse Events (AEs)
Time frame: Up to 3 years
Phase III: Overall Survival (OS)
Time frame: Up to 3 years
Phase III: Changes in serum chromogranin A, 24-hour urinary 5-hydroxyindoleacetic acid, and serum IGF-1 levels from baseline.
Time frame: From first dose of treatment to end of treatment
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