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NCT Number: NCT05884255

An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.

The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.

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Key information

Conditions

Advanced Gastroenteropancreatic Neuroendocrine Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • There are clinical symptoms or diseases of the heart that are not well controlled;
  • Diabetes (fasting blood glucose > 2 × ULN) that cannot be well controlled after optimal medical support treatment;
  • Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.

Treatment and study plan

Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide

Drug

Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.

long-acting Octreotide

Drug

High-dose long-acting Octreotide.

Primary outcomes

  1. Progression-free survival (PFS) assessed by BICR

    Time frame: Up to 1 year follow-up

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 5 years follow-up

  2. Objective Response Rate (ORR)

    Time frame: up to 1 year follow-up

  3. Duration of Overall Response (DoR)

    Time frame: Up to 1 year follow-up

  4. Disease Control Rate (DCR)

    Time frame: Up to 1 year follow-up

  5. Incidence and severity of adverse event (AE) and serious adverse event (SAE)

    Time frame: Up to 5 years follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Xueying Zheng

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Randomized, Open, Positive Control Phase III Clinical Trial of Lutetium (177Lu) Oxodotreotide Injection Combined With Standard-dose Long-acting Octreotide Versus High-dose Long-acting Octreotide in the Treatment of Somatostatin Receptor-positive Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Jun 1, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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