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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06300216
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Qilu Hospital of Shandong University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jing Hao, Dr.
Principal Investigator Affiliation Qilu hospital of Shandong University, China
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Tumors
Arms & Interventions

Arms

: Octreotide microspheres standard dose monotherapy

: Octreotide microspheres standard dose combination therapy

: Octreotide microspheres incremental or increased frequency therapy

: Octreotide microspheres maintenance therapy after targeted or chemotherapy

Interventions

Drug: - Octreotide microspheres

20mg/30mg Q4W

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Qilu hospital of Shandong University, Jinan, Shandong, China

Status

Address

Qilu hospital of Shandong University

Jinan, Shandong, 250012

Site Contact

Jian Wang, Dr.

wang.jian@sdu.edu.cn

8618560088226

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