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Compares treatment options for NETS Ga68 Lu177
Official title A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETs
ClinicalTrials.gov ID: NCT07057622
What this study is testing
What is 177Lu-DOTATATE injection?
177Lu-DOTATATE injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for nets ga68 lu177.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is to evaluate the sstr antagonists, 68Ga-DOTATATE and 177Lu-DOTATATE,as a pair of diagnostic/therapeuticradiopharmaceuticals(theranostics)in patients with NETS
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Somatostatin receptor positive patients must be defined as all target lesions at baseline confirmed by PET/ CT examination of gallium [68Ga]...
- There is at least one measurable lesion at baseline;
You likely can't join if
- 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)...
- 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;
- people who are receiving short-acting octreotide treatment cannot stop short-acting octreotide within 24 hours before and 24 hours after...
See the full eligibility 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...
- 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...
- people 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...
- 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...
- 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;
- people 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 people who are receiving Octreotide LAR...
- 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...
- Received the following treatments within 12 weeks before randomization,including but not limited to surgery (except biopsy),radical radiotherapy,hepatic artery treatment embolization,cryoablation or radiofrequency...
- Received palliative radiotherapy for bone metastases within 2 weeks before randomization;
- The toxicity of previous anti-tumor treatment has not recovered to s grade 1 level (except for hair loss and neurotoxicity);
- Known brain metastasis (except those who have received treatment and been stable for at least 24 weeks before randomization);
- Severe cardiac insufficiency,including congestive heart failure 2 grade 2 (New York Heart Association classification), myocardial infarction, stroke or transient ischemic attack (TIA) history within 6 months before...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.