A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine Tumors

Neuroendocrine Tumors Clinical Trial

Official title:

A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300216
• Other study ID #: KYLL-202401-034-1
• Status: Not yet recruiting
• Start date: March 26, 2024
• Est. completion date: May 26, 2028

Study information

• Verified date: February 2024
• Source: Qilu Hospital of Shandong University
• Contact: Jian Wang, Dr.
• Phone: 8618560088226
• Email: wang.jian[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this multicenter, open-label, observational study is to evaluate the safety and efficacy of octreotide microspheres in the treatment of advanced neuroendocrine tumors in real clinical practice, especially to evaluate the treatment of octreotide microspheres in various subgroups of neuroendocrine tumor patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 26, 2028
• Est. primary completion date: November 26, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Sign an informed consent form and voluntarily participate in this study;

2. Patients with unresectable or metastatic neuroendocrine tumors confirmed by histopathology. Patients with recurrence and progression after surgery or local treatment can also be included in the study;

3. Age = 18 years old;

4. Treatment with octreotide microspheres.

Exclusion Criteria:

1. Confirmed pregnant or lactating women;

2. Participating in any research with intervention measures outside of routine clinical practice;

3. Other situations unsuitable for inclusion in the study determined by the researcher.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• Octreotide microspheres
20mg/30mg Q4W

Locations

Country	Name	City	State
China	Qilu hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Emergent Adverse Events	Treatment emergent adverse events were recorded according to Common Terminology Criteria for Adverse Events (version 5.0) of the National Cancer Institute that participants received at least one dose of protocol treatment.	up to 46 months