RecruitingPhase 2NCT07437898

Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study

An Exploratory, Single-Arm, Multicenter Clinical Study of Neoadjuvant Adebrelimab Plus Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma


Sponsor

The Affiliated Hospital of Putian University

Enrollment

42 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a domestic exploratory, single-arm clinical study enrolling patients with histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma (ESCC), aiming to evaluate the efficacy and safety of neoadjuvant adebrelimab plus chemotherapy for locally advanced esophageal squamous cell carcinoma (ESCC).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called adebrelimab to standard chemotherapy before surgery improves outcomes for people with esophageal squamous cell cancer — a type of cancer in the lining of the food pipe. Participants receive treatment before surgery, then have surgery to remove the tumor. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with esophageal squamous cell cancer confirmed by biopsy - Your cancer is at a stage where surgery to fully remove it is planned and possible - You have not had any prior cancer treatment (no chemotherapy, radiation, or surgery for this cancer) - Your heart, liver, kidneys, and blood counts are in acceptable range **You may NOT be eligible if...** - Your tumor has grown into major blood vessels or the airway - You have an active autoimmune disease (like lupus, inflammatory bowel disease, or uncontrolled thyroid disease) - You have had a heart attack, heart failure, or severe heart rhythm problems - You are pregnant or breastfeeding - You have HIV or untreated active tuberculosis - You have had a severe infection requiring hospitalization in the past 4 weeks 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

DRUGAdebrelimab

Adebrelimab 1200 mg or 20 mg/kg, intravenous infusion, every 3 weeks (Q3W);

DRUGchemotherapy

nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) 100 mg/m² on Days 1 and 8 (D1/D8), intravenous infusion, every 3 weeks (Q3W); Cisplatin 75 mg/m² on Days 1, 2 and 3 (D1/D2/D3), intravenous infusion, every 3 weeks (Q3W).


Locations(1)

The Affiliated Hospital of Putian University

Putian, Fujian, China

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NCT07437898


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