NCT07057622
Recruiting
Phase 3
Compare the Safety and Efficacy of 177Lu-DOTATATE and Octreotide LAR in Unresectable or Metastatic, Progressive, Well-differentiated(G1 and G2) and SSTR-positive Adult GEP-NEN
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- HTA Co., Ltd.
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Compare the 18-month PFS rate of NET patients between 177Lu-DOTATATE Injection and long-acting octreotide
Overview
Brief Summary
The study is to evaluate the sstr antagonists, 68Ga-DOTATATE and 177Lu-DOTATATE,as a pair of diagnostic/therapeuticradiopharmaceuticals(theranostics)in patients with NETS
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability to understand and the willingness to sign a written informed consent document;
- •Age ≥18 years ;
- •Low-and medium-grade ( G1 or G2) unresectable locally advanced or metastaticgastrointestinalneuroendocrine tumors(GEP-NETs)confirmed by histopatholog in the central laboratory,and those who had previously progressed after standard-dose somatostatin analogue(SSA)treatment;
- •Somatostatin receptor positive patients must be defined as all target lesions at baseline confirmed by PET/ CT examination of gallium \[68Ga\] dobutamine injection as somatostatin receptor positive(IRC confirmed);
- •There is at least one measurable lesion at baseline;
- •BaselineECOG score 0 or 1;
- •Adeguate organ and bone marrow function as defined below:
- •a) bone marrow:Neutrophil count (ANC)≥1.5×109/L, platelet count ≥75×109/L,hemoglobin ≥80g/L,no blood transfusion or growth factor treatment within 14 days before randomization.(colony stimulating factor (CSF), colony stimulating factor (CSF),Erythropoietin(EPO),etc.); b) Liver function:aspartate aminotransferase(AST)and alanine aminotransferase(ALT)≤2.5 ULN; total bilirubin( TBIL ) ≤1.5 × ULN; c ) Renal function : serum creatinine ≤150μmol/ L or 1.7mg / dL, or creatinine clearance rate (CLcr)≥50mL/min calculated by Cockroft Gault method; d) Baseline left ventricular ejection fraction (LVEF)≥50 % measured by multi-gate circuit controlled acquisition(MUGA) or echocardiography(ECHO); e ) Coagulation function: international normalized ratio(INR)≤1.5 ×ULN,activated partial thromboplastin time(APTT ) ≤1.5 × ULN ; f) Serum albumin \> 3.0g/ dL.
- •Subjects with childbearing potential voluntarily use effective contraceptive methods,such as condoms, oral or injectable contraceptives, intrauterine devices, etc, during treatment and within 4 months (men) or 7months(women)after the last use of the investigational drug.
Exclusion Criteria
- •Human immunodeficiency virus (HIV) antibody positive;
- •Hepatitis B virus (HBV) surface antigen (HBsAg) is positive and HBV-DNA is positive (≥the upper limit of detection), or hepatitis C virus (HCV) antibody (HCV-Ab) is positive and HCV-RNA is positive (≥the upper limit of detection));
- •Pregnant or lactating women;
- •Received peptide receptor radionuclide therapy (PRRT) before randomization;
- •Received Octreotide LAR treatment with a dose intensity \>30 mg/3-4 weeks (increased dose or frequency) within 12 weeks before randomization;
- •Subjects who are receiving short-acting octreotide treatment cannot stop short-acting octreotide within 24 hours before and 24 hours after administration of 177Lu-DOTATATE or subjects who are receiving Octreotide LAR treatment cannot stop Octreotide LAR within 4 weeks before administration of 177Lu-DOTATATE;
- •Have received systemic anti-tumor treatments such as targeted therapy, immunotherapy,anti-tumor Chinese medicine treatment, chemotherapy,etc.within 4 weeks before randomization;
- •Participated in other drug clinical trials and received corresponding experimental drugs within 4 weeks before randomization, except for the PET/CT study of the diagnostic drug68Ga-DOTATATE injection initiated by the sponsor of this trial;
- •Received the following treatments within 12 weeks before randomization,including but not limited to surgery (except biopsy),radical radiotherapy,hepatic artery interventional embolization,cryoablation or radiofrequency ablation of liver metastases;
- •Received palliative radiotherapy for bone metastases within 2 weeks before randomization;
Arms & Interventions
177Lu-DOTATATE Injection
Experimental
Subjects in the test group are treated with 177Lu-DOTATATE injection, 7.4GBq±0.74GBq (200mCi±20mCi)/cycle, once every 8 to 12 weeks, 4 times in total.
Intervention: 177Lu-DOTATATE injection (Drug)
Octreotide LAR
Active Comparator
Subjects in the treatment group are treated with 60mg of long-acting octreotide once every 4 weeks±3 days.
Intervention: Octreotide LAR (Long-acting release) (Drug)
Outcomes
Primary Outcomes
Compare the 18-month PFS rate of NET patients between 177Lu-DOTATATE Injection and long-acting octreotide
Time Frame: 18 months from enrollment to PFS
Compare the 18-month PFS rate of NET patients between 177Lu-DOTATATE Injection and long-acting octreotide
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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