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

NCT05884255 | Recruiting Phase 3

• 1 other identifier: HRFS-Q-2011-301
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastroenteropancreatic Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) assessed by BICR

  Up to 1 year follow-up

Secondary Outcomes (5)

• 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

  Up to 1 year follow-up

• Incidence and severity of AE and SAE

  Up to 5 year follow-up

Study Arms (2)

Treatment group A

EXPERIMENTAL

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

Treatment group B

ACTIVE COMPARATOR

Drug: long-acting Octreotide

Interventions

long-acting Octreotide DRUG

High-dose long-acting Octreotide.

Treatment group B

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

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

Treatment group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent;
• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Tianjin University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Interventions

Lutetium; Lutetium-177

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Xueying Zheng

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: July 6, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)