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

NCT06698692 | Recruiting

• 1 other identifier: COSELA-ESCC-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

ESCC

Keywords

trilaciclib

Outcome Measures

Primary Outcomes (1)

• Incidence of grade ≥3 neutropenia

  Incidence of grade ≥3 neutropenia

  during Trilaciclib plus chemotherapy assessed up to 1 years

Secondary Outcomes (1)

• Incidence of Adverse Events

  during Trilaciclib plus chemotherapy assessed up to 1 years

Study Arms (2)

Observation group

Trilaciclib combined with chemoradiotherapy

Drug: Trilaciclib Injection [Cosela]

Control group

chemoradiotherapy

Interventions

Trilaciclib Injection [Cosela] DRUG

Trilaciclib Combined chemoradiotherapy

Observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with esophageal squamous carcinoma who received concurrent chemoradiotherapy with or without trilaciclib.

You may qualify if:

• age ≥18 years;
• pathological diagnosis of esophageal squamous cell carcinoma;
• failure to undergo surgical treatment;
• completion of definitive chemoradiotherapy or chemoradiotherapy combined with immunotherapy.

You may not qualify if:

• history of other malignant tumors;
• difficulty in follow-up;
• insufficient clinical information.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unsaved Biospecimen

MeSH Terms

Interventions

trilaciclib

Study Officials

• Xiao L Ge, PHD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolin Ge, PHD

CONTACT

86+83714511; doctorsxl@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: April 2, 2024
• Primary Completion: December 31, 2024
• Study Completion: April 2, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)