TheranosticTrials.org

Clinical Trial · NCT05894486

Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors

Overview

his was a single-center, single-arm phase II study evaluate the efficacy and safety of Lutetium\[177Lu\] Oxodotreotide Injection in the first-line treatment of unresectable or metastatic, progressive, G2 or G3, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.

Sponsor

Peking University First Hospital

Phase

Phase 2

Contacts

Ming Lu, professor (CONTACT)

qiminglu_mail@126.com

86-10-88196561

Zhi Yang, professor (CONTACT)

pekyz@163.com

13701382886

ClinicalTrials.gov

NCT05894486

Drug / Compound

Oxodotreotide

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Subjects have not received prior systemic antitumor therapy for the current stage of NET.
  • Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 3 months of the last use of the trial drug.
  • ECOG score of 0 or 1.
  • Histopathologically confirmed G2 or G3 unresectable locally advanced or metastatic GEP-NET, Ki67 index ≥10 and ≤ 55%. (based on the fifth edition of the WHO classification and grading criteria for neuroendocrine， tumors of the digestive system in 2019, to be centrally confirmed).
  • All target lesions (based on RECIST 1.1) at baseline must be confirmed as growth inhibitor receptor positive by 68Ga-Dotatate PET/CT.
  • Presence of at least 1 measurable site of disease (based on RECIST 1.1).

Exclusion

  • Serum total bilirubin \> 3 × upper limit of normal (ULN).
  • Received the following treatments within 4 weeks prior to treatment, including but not limited to surgery (except biopsy), radical radiotherapy, hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation.
  • Received peptide receptor radionuclide therapy(PRRT) prior to randomization.
  • Uncontrolled congestive heart failure.
  • International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 x ULN.
  • Known to be unsuitable for enhanced CT or MRI contrast imaging due to allergic reaction or renal insufficiency
  • Any other disease, mental status or surgical condition that is uncontrolled, may interfere with study completion (including poor compliance) or is inappropriate for the use of the investigational drug.
  • Received external beam radiation therapy for bone metastases within 2 weeks prior to treatment.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5×ULN.
  • uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x ULN.
  • Hemoglobin \<80g/L, or white blood cell count \<2.0×109/L, or platelets \<75×109/L.
  • Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinion of the investigator, are more appropriate for the patient than the treatment provided in the study based on the patient's disease characteristics, i.e., the investigational drug is not the best therapeutic agent for clinical practice.
  • Serum creatinine \>150 μmol/L (1.7 mg/dL) or creatinine clearance \<50 ml/min (Cockcroft Gault formula).
  • Subjects who, in the judgment of the investigator, are suspected of having a disease or condition that makes them unsuitable for the study drug disease or condition.
  • Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to randomization.
  • Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study.
  • Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted 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 of Lutetium\[177Lu\] Oxodotreotide Injection.
  • Toxicity of prior antitumor therapy has not returned to ≤ grade 1 levels (except for alopecia).
  • Participated in other drug clinical trials within 4 weeks prior to the first treatment and received treatment with the corresponding trial drug.
  • Any clinically significant active infection, including Positive human immunodeficiency virus (HIV) antibody.
  • Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and positive for HBV DNA (≥1×104 copies/ml or judged positive by research center criteria), or positive for hepatitis C virus (HCV) antibodies.
  • Known hypersensitivity to Lutetium\[177Lu\] Oxodotreotide Injection or oxytetracycline acetate microsphere components and their excipients.
  • Pregnant or lactating females.
  • Serum albumin \<30g/L.
  • Known other malignancies (except for those without recurrence within 5 years after adequate treatment)
  • More than 25% of bone marrow with prior external radiation radiotherapy.