RecruitingPhase 2NCT06569459

Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer

A Prospective, Randomized, Controlled, Single-center Phase II Clinical Trial of Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy for Locally Advanced Esophageal Cancer.


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

60 participants

Start Date

Jul 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a double-arm, randomized, controlled, single-center, phase II clinical trial aimed at evaluating the efficacy and safety of chemoradiotherapy plus immunotherapy with or without Trilaciclib in the treatment of locally advanced esophageal squamous cell carcinoma that is not resectable.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called trilaciclib combined with standard chemoradiation and immunotherapy for people with locally advanced esophageal squamous cell carcinoma (cancer of the food pipe). Trilaciclib is designed to protect the bone marrow from being damaged during chemotherapy and radiation, potentially reducing serious side effects like low blood counts. **You may be eligible if:** - You are 18 or older with histologically confirmed locally advanced esophageal squamous cell carcinoma - Your cancer is at stage II-IV and is not suitable for surgery, or you have refused surgery - You have at least one measurable tumor - You have not received any prior systemic anti-cancer therapy (chemotherapy, radiation, immunotherapy, targeted therapy) **You may NOT be eligible if:** - You have already received any systemic cancer treatment (chemotherapy, immunotherapy, radiation, etc.) - You have distant organ metastases (cancer spread to organs like the liver or lungs) - Your general health is too poor to tolerate treatment - You do not have measurable disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrilaciclib Injection [Cosela]

Chemoradiotherapy and immunotherapy with Trilaciclib in the treatment of patients with unresectable locally advanced esophageal squamous cell carcinoma

DRUGPlacebo

Chemoradiotherapy and immunotherapy in the treatment of patients with unresectable locally advanced esophageal squamous cell carcinoma


Locations(1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06569459


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