Actively Recruiting
Real-world Assessment of Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-11-21
200
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of trilaciclib, a drug designed to protect bone marrow, in patients with esophageal squamous cell carcinoma (ESCC) who are undergoing chemoradiotherapy. Chemoradiotherapy-induced myelosuppression (CIM) is a common and serious side effect that can cause delays or changes in cancer treatment. This study explores trilaciclib's safety and effectiveness in preventing myelosuppression during treatment, a first for this type of cancer. The study compares two groups of patients: one receiving trilaciclib combined with chemoradiotherapy and a control group receiving only chemoradiotherapy. Trilaciclib is given before each chemotherapy session. Researchers collected clinical data from patients treated at Jiangsu Provincial People's Hospital and used statistical methods to balance characteristics between the groups, then compared rates of bone marrow suppression and other adverse events. Participants are monitored for the incidence of severe neutropenia and other side effects during treatment and up to one year afterward. Data collection includes clinical assessments and the recording of adverse events. The study aims to provide real-world evidence on whether trilaciclib can reduce myelosuppression related to chemoradiotherapy in ESCC patients, helping to maintain treatment schedules and improve patient outcomes.
CONDITIONS
Brief Title
Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathological diagnosis of esophageal squamous cell carcinoma
- Not eligible for surgical treatment
- Completed definitive chemoradiotherapy or chemoradiotherapy combined with immunotherapy
You will not qualify if you...
- History of other malignant tumors
- Difficulty in follow-up
- Insufficient clinical information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of chemoradiotherapy treatment period
Participants receive trilaciclib combined with chemoradiotherapy or chemoradiotherapy alone to prevent chemoradiotherapy-induced myelosuppression.
Visits aligned with chemoradiotherapy schedule
Duration - Up to 1 year
Participants are monitored for up to 1 year to assess incidence of neutropenia and adverse events after treatment.
Periodic follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
X
Xiaolin Ge, PHD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here