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

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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05884255

Enrollment

220

Registered

2023-06-01

Start date

2023-07-06

Completion date

2030-10-01

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Gastroenteropancreatic Neuroendocrine Tumor

Brief summary

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

Interventions

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

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

DRUGlong-acting Octreotide

High-dose long-acting Octreotide.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) assessed by BICR	Up to 1 year follow-up

Secondary

Measure	Time frame
Overall Survival (OS)	Up to 5 years follow-up
Objective Response Rate (ORR)	up to 1 year follow-up
Duration of Overall Response (DoR)	Up to 1 year follow-up
Disease Control Rate (DCR)	Up to 1 year follow-up
Incidence and severity of adverse event (AE) and serious adverse event (SAE)	Up to 5 years follow-up

Countries

China

Contacts

CONTACTXueying Zheng

xueying.zheng.xz17@hengrui.com+86-0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026