Clinical trial NCT06698692: Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma
Official title: Real-world Assessment of Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ESCC
Keywords: trilaciclib
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with esophageal squamous carcinoma who received concurrent chemoradiotherapy with or without 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of grade ≥3 neutropenia
timeFrame: during Trilaciclib plus chemotherapy assessed up to 1 years
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: during Trilaciclib plus chemotherapy assessed up to 1 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiao L Ge, PHD
role: PRINCIPAL_INVESTIGATOR
References: