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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05884255
Collaborator
(none)
220
Enrollment
2
Arms
88
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide
  • Drug: long-acting Octreotide.
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Oct 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group A

Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide
Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide
Active Comparator: Treatment group B

Drug: long-acting Octreotide.
High-dose long-acting Octreotide.

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) assessed by BICR [up to 1 years follow-up]

Secondary Outcome Measures

  1. Overall Survival(OS) [up to 5 years follow-up]

  2. Objective Response Rate(ORR) [up to 1 years follow-up]

  3. Duration of Overall Response(DoR) [up to 1 years follow-up]

  4. Disease Control Rate [up to 1 years follow-up]

  5. Incidence and severity of AE and SAE [up to 5 years follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05884255
Other Study ID Numbers:
  • HRFS-Q-2011-301
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neuroendocrine Tumors
Octreotide
Lutetium Lu 177 dotatate

Study Results

No Results Posted as of Jun 1, 2023