Actively Recruiting
A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETs
Led by HTA Co., Ltd. · Updated on 2025-07-10
184
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is to evaluate the sstr antagonists, 68Ga-DOTATATE and 177Lu-DOTATATE,as a pair of diagnostic/therapeuticradiopharmaceuticals(theranostics)in patients with NETS
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingly sign informed consent
- Age 18 years or older
- Diagnosis of low- or medium-grade (G1 or G2) unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors confirmed by histopathology
- Prior progression after standard-dose somatostatin analogue treatment
- Somatostatin receptor positive confirmed by PET/CT of gallium [68Ga] DOTATATE injection
- At least one measurable lesion at baseline
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function: neutrophil count 61.5�d7109/L, platelet count 675�d7109/L, hemoglobin 680 g/L, no recent blood transfusion or growth factor treatment within 14 days
- Liver function: AST and ALT 62.5 times upper limit of normal, total bilirubin 61.5 times upper limit of normal
- Renal function: serum creatinine 6150 bcmol/L or 1.7 mg/dL, or creatinine clearance 650 mL/min
- Left ventricular ejection fraction 650%
- Coagulation function: INR and APTT 61.5 times upper limit of normal
- Serum albumin 3.0 g/dL or higher
- Use of effective contraception during treatment and for 4 months (men) or 7 months (women) after last dose
You will not qualify if you...
- Positive for HIV antibody
- Positive for hepatitis B surface antigen and HBV-DNA or hepatitis C antibody and HCV-RNA above detection limits
- Pregnant or breastfeeding women
- Previous peptide receptor radionuclide therapy before randomization
- Octreotide LAR treatment with dose intensity above 30 mg per 3-4 weeks within 12 weeks before randomization
- Inability to stop short-acting or long-acting octreotide within required time before 177Lu-DOTATATE administration
- Use of systemic anti-tumor treatments (targeted therapy, immunotherapy, chemotherapy, etc.) within 4 weeks before randomization
- Participation in other drug trials with experimental drugs within 4 weeks before randomization (except 68Ga-DOTATATE PET/CT study)
- Recent surgery, radical radiotherapy, embolization, cryoablation, or radiofrequency ablation within 12 weeks before randomization
- Palliative radiotherapy for bone metastases within 2 weeks before randomization
- Unresolved toxicity from previous anti-tumor treatments above grade 1 (except hair loss and neurotoxicity)
- Known brain metastases unless stable for at least 24 weeks
- Severe cardiac insufficiency or recent serious cardiac events within 6 months
- History of ventricular tachycardia, torsade de pointes, or significant ECG abnormalities
- Pulmonary embolism or deep vein thrombosis within 3 months
- Uncontrolled hypertension or diabetes
- Active infections requiring intravenous treatment within 2 weeks
- Other concurrent malignant tumors within 5 years (with specific exceptions)
- Allergies to 68Ga-DOTATATE, 177Lu-DOTATATE, or Octreotide LAR or their components
- Any uncontrolled disease or mental state affecting study completion or unsuitability for study drugs
- Investigator judgment that alternative treatments are more appropriate than study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
L
Li Huo, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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