Radioactive injection shows promise in slowing neuroendocrine tumor growth

NCT ID NCT05459844

Disease control Sponsor: Sinotau Pharmaceutical Group Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 3 study tested a radioactive drug called Lutetium-177 oxodotreotide against a high dose of the standard drug octreotide in 196 people with advanced neuroendocrine tumors that had stopped responding to treatment. The main goal was to see if the radioactive drug could delay tumor growth better than octreotide. Participants received either four injections of the radioactive drug or regular octreotide shots, and their tumors were monitored over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Lutetium-177 oxodotreotide injection (a type of radioactive drug)
What this could lead to: If this treatment works, it could offer a more effective option to slow tumor growth in people with advanced neuroendocrine tumors that are no longer controlled by standard therapy.
What could go wrong: This is a Phase 3 trial, but results are not yet published. The radioactive drug may cause side effects like kidney or bone marrow damage, and not all patients may respond.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

196 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 locally advanced or metastatic GEP-NET (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). 4. Previously received fixed-dose Octreotide LAR (20-30 mg/3-4 weeks) for at least 12 weeks of continuous treatment with disease progression. 5. Presence of disease progression prior to randomization (time point of disease progression limited to 1 year prior to randomization and no other antitumor therapy received 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 as somatostatin receptor positive by 68Ga-Dotatate PET/CT . 8. ECOG score of 0 or 1. 9. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 4 months (men) or 7 months (women) of the last use of the 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 HBV DNA (≥1×10\^4 copies/ml or judged positive by research center criteria), or positive for 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 or frequency) within 12 weeks prior to randomization. 12. 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. 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 and received treatment with the corresponding trial drug. 15. Received the following treatments within 12 weeks prior to randomization, including but not limited to surgery (except biopsy), radical radiotherapy, hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation. 16. Received external beam radiation therapy for bone metastases within 2 weeks prior to randomization 17. Toxicity of prior antitumor therapy has not returned to ≤ grade 1 levels (except for alopecia) 18. Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study. 19. Uncontrolled congestive heart failure, including baseline left ventricular ejection fraction (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 after adequate treatment) 23. Known hypersensitivity to Lutetium\[177Lu\] Oxodotreotide Injection or oxytetracycline acetate microsphere components and their excipients. 24. Known to be unsuitable for enhanced CT or MRI contrast imaging due to allergic reaction or renal insufficiency. 25. 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. 26. 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.

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine tumor, grade 1/2 neuroendocrine neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuroendocrine tumors

Contacts and locations

Locations

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China
Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China
Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China
Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China
Mianyang Central Hospital

Mianyang, Sichuan, 621099, China
Nanjing First Hospital

Nanjing, Jiangsu, 210006, China
Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China
The First Affiliated Hospital of AFMU

Xi'an, Shaanxi, 710032, China
The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China
The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030012, China
The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China
The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China
The First Afilliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China
The first hospital of Jilin University

Changchun, Jilin, 130021, China
Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 430030, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China
West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China
Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China
Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

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