The purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET.
Male or female patient ≥18 years old;
Histologically confirmed, advanced GEP-NET;
At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1;
Previous treatment with ≤2 systemic antitumor drugs;
Uncontrolled or severe diarrhea with significant dehydration;
Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection;
Anti-tumor therapy received within 4 weeks prior to the initiation of the investigational treatment, for example mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase inhibitors (TKI); or short-acting octreotide acetate was received subcutaneously or intravenously within 1 weeks prior to the initiation of the investigational treatment;
Interferon was received within 4 weeks prior to the initiation of the investigational treatment; or chemotherapy was received within 4 weeks prior to the initiation of the investigational treatment; or transarterial chemoembolization was received within 12 months prior to screening; or previously received peptide receptor radionuclide therapy (PRRT) at any time; or received radiation therapy, anti-tumor traditional Chinese medicine treatment, hepatic artery intervention embolization, liver metastasis cryoablation or radiofrequency ablation, and other systemic anti-tumor drug treatments within 4 weeks prior to the initiation of the investigational treatment; or had participated in other clinical trials within 30 days prior to screening
Parallel
SYHX2008 injection
DrugThe patients will accept SYHX2008 injection by subcutaneous administration every cycle.
Sandostatin LAR@
DrugThe patients will accept Sandostatin LAR@ by intra-muscular administration every cycle.
Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)
Overall survival (OS)
The time from the date of randomization to the date of death due to any cause
PFS as assessed by local Investigators
PFS as assessed by local Investigators
Overall response rate(ORR)
The proportion of patients with best overall response of complete response (CR) or partial response (PR), according to RECIST 1.1
Disease control rate (DCR)
The proportion of patients with a best overall response of CR, PR or stable disease (SD), according to RECIST 1.1
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