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

Phase 3

Recruiting

• Conditions: Advanced Gastroenteropancreatic Neuroendocrine Tumor
• Interventions: Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide; Drug: long-acting Octreotide.

• Registration Number: NCT05884255
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-01
• Study Start: 2023-07-06
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09
• Primary Completion: 2026-12
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide	-
Treatment group B	long-acting Octreotide.	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) assessed by BICR	up to 1 years follow-up

Secondary Outcome Measures

Name	Time	Method
Overall Survival(OS)	up to 5 years follow-up
Objective Response Rate(ORR)	up to 1 years follow-up
Duration of Overall Response(DoR)	up to 1 years follow-up
Disease Control Rate	up to 1 years follow-up
Incidence and severity of AE and SAE	up to 5 years follow-up

Trial Locations

Locations (1)

Tianjin University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China