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RecruitingPhase 1NCT06225921

Neoadjuvant Adebrelimab With Dalpiciclib for Resectable Esophageal Squamous Cell Carcinomas

The Safety and Feasibility of Neoadjuvant Adebrelimab With Dalpiciclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial

Sponsor

West China Hospital

Enrollment

6 participants

Start Date

Dec 29, 2023

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

Summary

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death ligand 1(PD-L1) immunotherapy, Adebrelimab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two new drugs — adebrelimab (an immunotherapy) and dalpiciclib — given before surgery in patients with a type of throat cancer called esophageal squamous cell carcinoma. The aim is to shrink the tumor before removing it. **You may be eligible if...** - Your cancer has been confirmed by biopsy as esophageal squamous cell carcinoma located in the chest - Doctors believe your cancer can be removed with surgery - You are between 18 and 75 years old - You are in good enough physical condition to undergo surgery **You may NOT be eligible if...** - Your cancer has grown into surrounding structures and cannot be surgically removed (T4b stage) - You are currently receiving chemotherapy, radiation, targeted therapy, or immunotherapy - You have a history of another cancer - You are pregnant or breastfeeding 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

DRUGDalpiciclib 150mg

Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.

DRUGAdebrelimab

Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.

DRUGDalpiciclib 100mg

Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.

Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT06225921

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