Observational study on immune checkpoint inhibitors for cancer treatment
Multicenter Observational Prospective Study of Immune Checkpoint Inhibitors in Patients With Solid Neoplasms
Fudan University · NCT04766515
This study looks at how well immune checkpoint inhibitors work and their safety for people with solid tumors in everyday treatment settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04766515 on ClinicalTrials.gov |
What this trial studies
This observational study involves patients with solid tumors who are receiving immune checkpoint inhibitors (ICIs) in a real-world clinical setting. It aims to evaluate the effectiveness, safety, and usage patterns of ICIs across various tumor types and stages. By collecting data from multiple centers, the study seeks to provide insights that can inform clinical decisions regarding cancer treatment with ICIs. The findings may help understand how these therapies perform outside of controlled clinical trials.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of solid tumor cancer who are currently receiving immune checkpoint inhibitors.
Not a fit: Patients with hematological malignancies, solid benign tumors, or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of immune checkpoint inhibitors' effectiveness and safety in treating solid tumors, leading to improved patient outcomes.
How similar studies have performed: Other studies have shown promising results with immune checkpoint inhibitors in various cancers, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age at least 18 years. * Pathologically confirmed diagnosis of a solid tumor cancer. * Patients receiving treatment with immune checkpoint inhibitors. * Ability to understand and willingness to provide the informed consent. Exclusion Criteria: * Age \< 18 years. * Patients with hematological malignancies or solid benign tumors. * Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
Where this trial is running
Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Zhengfei Zhu, MD — Fudan University
- Study coordinator: Zhengfei Zhu, MD
- Email: fuscczzf@163.com
- Phone: +86-18017312901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer