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

NCT06300216 | Not Yet Recruiting

• 1 other identifier: KYLL-202401-034-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Octreotide microspheres standard dose monotherapy

Drug: Octreotide microspheres

Octreotide microspheres standard dose combination therapy

Octreotide microspheres incremental or increased frequency therapy

Octreotide microspheres maintenance therapy after targeted or chemotherapy

Interventions

Octreotide microspheres DRUG

20mg/30mg Q4W

Octreotide microspheres standard dose monotherapy

Eligibility Criteria

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

Study Population

Patients with advanced neuroendocrine tumors treated with octreotide microspheres will be eligible to participate in the study.

You may qualify if:

• Sign an informed consent form and voluntarily participate in this study;
• 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;
• Age ≥ 18 years old;
• Treatment with octreotide microspheres.

You may not qualify if:

• Confirmed pregnant or lactating women;
• Participating in any research with intervention measures outside of routine clinical practice;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Jing Hao, Dr.

  Qilu hospital of Shandong University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Wang, Dr.

CONTACT

8618560088226; wang.jian@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 8, 2024
• Study Start: March 26, 2024
• Primary Completion (Estimated): November 26, 2027
• Study Completion (Estimated): May 26, 2028
• Last Updated: March 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)