Back to resultsAn Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
Primary Purpose
Advanced Gastroenteropancreatic Neuroendocrine Tumor
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide
long-acting Octreotide.
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastroenteropancreatic Neuroendocrine Tumor
Eligibility Criteria
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
Sites / Locations
- Tianjin University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group A
Treatment group B
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival (PFS) assessed by BICR
Secondary Outcome Measures
Overall Survival(OS)
Objective Response Rate(ORR)
Duration of Overall Response(DoR)
Disease Control Rate
Incidence and severity of AE and SAE
Full Information
NCT ID
NCT05884255
First Posted
May 22, 2023
Last Updated
August 7, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05884255
Brief Title
An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
October 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastroenteropancreatic Neuroendocrine Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Experimental
Arm Title
Treatment group B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide
Intervention Description
Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide
Intervention Type
Drug
Intervention Name(s)
long-acting Octreotide.
Intervention Description
High-dose long-acting Octreotide.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) assessed by BICR
Time Frame
up to 1 years follow-up
Secondary Outcome Measure Information:
Title
Overall Survival(OS)
Time Frame
up to 5 years follow-up
Title
Objective Response Rate(ORR)
Time Frame
up to 1 years follow-up
Title
Duration of Overall Response(DoR)
Time Frame
up to 1 years follow-up
Title
Disease Control Rate
Time Frame
up to 1 years follow-up
Title
Incidence and severity of AE and SAE
Time Frame
up to 5 years follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xueying Zheng
Phone
+0518-82342973
Email
xueying.zheng.xz17@hengrui.com
Facility Information:
Facility Name
Tianjin University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihui Hao
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
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