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

Recruiting

• Conditions: ESCC
• Interventions: Drug: Trilaciclib Injection [Cosela]

• Registration Number: NCT06698692
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study Start: 2024-04-02
• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Primary Completion: 2024-12-31
• Study Completion: 2025-04-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation group	Trilaciclib Injection [Cosela]	Trilaciclib combined with chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
Incidence of grade ≥3 neutropenia	during Trilaciclib plus chemotherapy assessed up to 1 years	Incidence of grade ≥3 neutropenia

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	during Trilaciclib plus chemotherapy assessed up to 1 years	The incidence of Adverse Events according to Common Terminology Criteria for Adverse Events

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China