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Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma

Real-world Assessment of Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06698692
Acronym
COSELA
Enrollment
200
Registered
2024-11-21
Start date
2024-04-02
Completion date
2025-04-02
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESCC

Keywords

trilaciclib

Brief summary

Clinical data of patients with synchronous radiotherapy for esophageal cancer in the Department of Radiology of Jiangsu Provincial People's Hospital were collected. Patients were divided into trilaciclib group (34 cases) and control group (169 cases) based on whether trilaciclib was used or not. Patients in the trilaciclib group were given trilaciclib before each chemotherapy treatment. Propensity score matching (PSM) was used to balance the baseline characteristics between the two groups on a 1:1 ratio. After pairing, the rates of bone marrow suppression and other adverse events were compared between the two groups.

Detailed description

chemoradiotherapy-induced myelosuppression (CIM) is the most common adverse event of concurrent chemoradiotherapy for esophageal cancer, often leading to reduction, delay or even cessation of chemotherapeutic agents. Clinical treatments for CIM mainly include various hematopoietic growth factors and blood transfusion. However, these interventions target only a single spectrum of blood cells and are susceptible to concomitant adverse events such as bone pain, thrombosis, and fever. Trilaciclib is a potent, transient, reversible CDK4/6 inhibitor and is the world's first innovative drug with lineage-wide myeloprotective effects. Its use in esophageal cancer has not been reported yet. In this study, we investigated the clinical efficacy and safety of trilaciclib in preventing myelosuppression in concurrent chemoradiotherapy for esophageal cancer for the first time.

Interventions

Trilaciclib Combined chemoradiotherapy

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of grade ≥3 neutropeniaduring Trilaciclib plus chemotherapy assessed up to 1 yearsIncidence of grade ≥3 neutropenia

Secondary

MeasureTime frameDescription
Incidence of Adverse Eventsduring Trilaciclib plus chemotherapy assessed up to 1 yearsThe incidence of Adverse Events according to Common Terminology Criteria for Adverse Events

Countries

China

Contacts

Primary ContactXiaolin Ge, PHD
doctorsxl@163.com86+83714511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026