Treatment for advanced gastrointestinal pancreatic neuroendocrine tumors using Lutetium (177Lu) Oxodotreotide Injection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of Lutetium (177Lu) Oxodotreotide Injection in patients with advanced gastrointestinal pancreatic neuroendocrine tumors. It is an open-label Phase 3 study that includes patients aged 18 to 75 with unresectable locally advanced or metastatic tumors of low and medium grade. Participants will receive the injection along with long-acting Octreotide as part of the treatment regimen. The study aims to determine how well this treatment works compared to existing options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. 18\~75 years old,male or female;
3. ECOG performance status 0 or 1;
4. Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors (GEP-NETs) of low and medium grade (G1 or G2) confirmed by histopathology.

Exclusion Criteria:

1. Central nervous system metastasis is known. Patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized pre-imaging is confirmed to be stable for at least 24 weeks;
2. There are clinical symptoms or diseases of the heart that are not well controlled;
3. Diabetes (fasting blood glucose \> 2 × ULN) that cannot be well controlled after optimal medical support treatment;
4. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Tianjin University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Xueying Zheng
• Email: xueying.zheng.xz17@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.