RecruitingPhase 2NCT06663059

Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study

A Prospective, Multicenter, Exploratory Study Comparing 2 Cycles Versus 4 Cycles of Adebrelimab Combined With Chemotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma


Sponsor

Tang-Du Hospital

Enrollment

80 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different treatment schedules before surgery in patients with locally advanced esophageal squamous cell carcinoma (a type of throat cancer): 2 cycles versus 4 cycles of the immunotherapy drug adebrelimab combined with chemotherapy, to find out which approach is safer and more effective before tumor removal surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with locally advanced esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is in the chest portion of the esophagus and has not spread to distant organs - You have never received any prior treatment for esophageal cancer (no radiation, chemotherapy, or surgery) - Surgery is planned after completing the treatment, and you are considered a good surgical candidate - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have received any prior treatment for esophageal cancer - Your cancer has spread to distant parts of the body (stage IV) - You have serious organ function problems or blood abnormalities - You have contraindications to surgery - 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

DRUGAdebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle

Each treatment cycle is 3 weeks long (Q3W), with a total of 2 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W. Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W. Drug infusion should follow this sequence: Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion.

DRUGAdebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle

Each treatment cycle is 3 weeks long (Q3W), with a total of 4 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W. Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W. Drug infusion should follow this sequence: Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion.


Locations(1)

Tangdu Hospital Affiliated to the Fourth Military Medical University

Xi'an, Shannxi, China

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NCT06663059


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