Using trilaciclib to prevent bone marrow suppression in esophageal cancer treatment
Real-world Assessment of Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma
This study is testing if giving trilaciclib before chemotherapy can help prevent bone marrow problems in people with esophageal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06698692 on ClinicalTrials.gov |
What this trial studies
This study collects clinical data from patients with esophageal squamous cell carcinoma undergoing concurrent chemoradiotherapy. Patients are divided into two groups: one receiving trilaciclib before chemotherapy and a control group not receiving it. The study employs propensity score matching to ensure balanced baseline characteristics between the groups, allowing for a fair comparison of bone marrow suppression rates and other adverse events. This is the first investigation into the efficacy and safety of trilaciclib for this purpose in esophageal cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a pathological diagnosis of esophageal squamous cell carcinoma who cannot undergo surgical treatment.
Not a fit: Patients with a history of other malignant tumors or those unable to provide sufficient clinical information may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of myelosuppression in patients undergoing treatment for esophageal cancer.
How similar studies have performed: While this specific application of trilaciclib is novel, similar studies have shown promise in using CDK4/6 inhibitors for myeloprotection in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥18 years; * pathological diagnosis of esophageal squamous cell carcinoma; * failure to undergo surgical treatment; * completion of definitive chemoradiotherapy or chemoradiotherapy combined with immunotherapy. Exclusion Criteria: * history of other malignant tumors; * difficulty in follow-up; * insufficient clinical information.
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Xiao L Ge, PHD — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Xiaolin Ge, PHD
- Email: doctorsxl@163.com
- Phone: 86+83714511
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.