A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs

Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.

2. Aged 18 years or older.

3. Histopathologically confirmed low and moderate grade (G1 or G2) unresectable locallyadvanced or metastatic GEP-NET (based on the fifth edition of the WHO classificationand grading criteria for neuroendocrine tumors of the digestive system in 2019, tobe centrally confirmed).

4. Previously received fixed-dose Octreotide LAR (20-30 mg/3-4 weeks) for at least 12weeks of continuous treatment with disease progression.

5. Presence of disease progression prior to randomization (time point of diseaseprogression limited to 1 year prior to randomization and no other antitumor therapyreceived after progression).

6. Presence of at least 1 measurable site of disease (based on RECIST 1.1).

7. All target lesions (based on RECIST 1.1) at baseline must be confirmed assomatostatin receptor positive by 68Ga-Dotatate PET/CT .

8. ECOG score of 0 or 1.

9. Subjects of childbearing potential voluntarily use an effective method ofcontraception, such as condoms, oral or injectable contraceptives, IUDs, etc.,during treatment and within 4 months (men) or 7 months (women) of the last use ofthe trial drug.

Exclusion Criteria:

1. Serum creatinine >150 μmol/L (1.7 mg/dL) or creatinine clearance <50 ml/min (Cockcroft Gault formula).

2. Hemoglobin <80g/L, or white blood cell count <2.0×10^9/L, or platelets <75×10^9/L.

3. Serum total bilirubin > 3 × upper limit of normal (ULN).

4. Serum albumin <30g/L.

5. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5×ULN.

6. international normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 x ULN.

7. Positive human immunodeficiency virus (HIV) antibody.

8. Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and positive for HBVDNA (≥1×10^4 copies/ml or judged positive by research center criteria), or positivefor hepatitis C virus (HCV) antibodies.

9. Pregnant or lactating females.

10. Received peptide receptor radionuclide therapy(PRRT) prior to randomization.

11. Received Octreotide LAR at a dose strength >30 mg/3-4 weeks (increasing dose orfrequency) within 12 weeks prior to randomization.

12. Any patient receiving treatment with short-acting Octreotide, which cannot beinterrupted for 24 h before and 24 h after the administration of Lutetium[177Lu]Oxodotreotide Injection, or any patient receiving treatment with Octreotide LAR,which cannot be interrupted for at least 6 weeks before the administration ofLutetium[177Lu] Oxodotreotide Injection.

13. Received systemic antitumor therapy such as targeted therapy, immunotherapy,antitumor herbal therapy, chemotherapy within 4 weeks prior to randomization.

14. Participated in other drug clinical trials within 4 weeks prior to randomization andreceived treatment with the corresponding trial drug.

15. Received the following treatments within 12 weeks prior to randomization, includingbut not limited to surgery (except biopsy), radical radiotherapy, hepatic arteryinterventional embolization, cryoablation of liver metastases, or radiofrequencyablation.

16. Received external beam radiation therapy for bone metastases within 2 weeks prior torandomization

17. Toxicity of prior antitumor therapy has not returned to ≤ grade 1 levels (except foralopecia)

18. Known brain metastases, unless these metastases have been treated and stabilized forat least 24 weeks, prior to enrollment in the study.

19. Uncontrolled congestive heart failure, including baseline left ventricular ejectionfraction (LVEF) <50%.

20. uncontrolled diabetes mellitus, including baseline fasting glucose > 2 x ULN.

21. Any clinically significant active infection.

22. Known other malignancies (except for those without recurrence within 5 years afteradequate treatment)

23. Known hypersensitivity to Lutetium[177Lu] Oxodotreotide Injection or oxytetracyclineacetate microsphere components and their excipients.

24. Known to be unsuitable for enhanced CT or MRI contrast imaging due to allergicreaction or renal insufficiency.

25. Any other disease, mental status or surgical condition that is uncontrolled, mayinterfere with study completion (including poor compliance) or is inappropriate forthe use of the investigational drug.

26. Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinionof the investigator, are more appropriate for the patient than the treatmentprovided in the study based on the patient's disease characteristics, i.e., theinvestigational drug is not the best therapeutic agent for clinical practice.