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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuroendocrine Tumors
• Intervention / Treatment: Drug: Octreotide microspheres

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jian Wang, Dr.; Phone Number: 8618560088226; Email: wang.jian@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
      • Contact: Jian Wang, Dr.; Phone Number: 8618560088226; Email: wang.jian@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Octreotide microspheres standard dose monotherapy	Drug: Octreotide microspheres; 20mg/30mg Q4W
Octreotide microspheres standard dose combination therapy
Octreotide microspheres incremental or increased frequency therapy
Octreotide microspheres maintenance therapy after targeted or chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Jing Hao, Dr., Qilu hospital of Shandong University, China

Study record dates

Study Major Dates

• Study Start (Estimated): March 26, 2024
• Primary Completion (Estimated): November 26, 2027
• Study Completion (Estimated): May 26, 2028

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: KYLL-202401-034-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No