NCT06569459

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The subjects included in the study will receive Trilaciclib combined with chemoradiotherapy and immunosuppressant group ( the experimental group) and chemoradiotherapy combined with immunosuppressant group ( the control group). The experimental group and the control group were treated with 4 cycles of treatment. If the efficacy was evaluated as non-progressive after 4 cycles of treatment, the experimental group and the control group continued immunosuppressive therapy until disease progression or intolerance. The incidence of grade ≥3 neutropenia during chemotherapy was used as the primary endpoint.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Trilaciclib Injection [Cosela]	Chemoradiotherapy and immunotherapy with Trilaciclib in the treatment of patients with unresectable locally advanced esophageal squamous cell carcinoma
DRUG	Placebo	Chemoradiotherapy and immunotherapy in the treatment of patients with unresectable locally advanced esophageal squamous cell carcinoma

Timeline

• Start date: 2024-07-09
• Primary completion: 2025-11-30
• Completion: 2026-07-31
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: China