RecruitingPhase 2NCT06601309

Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC

Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: an Exploratory Phase II Single-arm Clinical Study


Sponsor

Fujian Medical University Union Hospital

Enrollment

90 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing personalised treatment strategies for people with locally advanced esophageal squamous cell carcinoma (a type of throat/food-pipe cancer) before surgery, using biomarkers — including a protein called PD-L1 — to guide which combination of chemotherapy and immunotherapy to use. **You may be eligible if...** - You have been confirmed by biopsy to have esophageal squamous cell carcinoma - Your cancer is locally advanced (Stage II or III) and can potentially be removed by surgery - You are between 18 and 75 years old - Your overall health is good (ECOG performance status 0 or 1) - Your PD-L1 expression level has been tested - A thoracic surgeon has confirmed you are eligible for surgical resection - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have had another cancer in the past 5 years (with some exceptions) - You have active autoimmune disease requiring systemic treatment in the past 2 years - You have an active infection requiring treatment - You have other serious uncontrolled medical conditions 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

DRUGSerplulimab

Serplulimab (300 mg) administered intravenously on day 1 of each 21-day cycle for 2 cycles.

DRUGPaclitaxel+Cisplatin (Neoadjuvant Chemotherapy)

Paclitaxel (175 mg/m²) and Cisplatin (75 mg/m²) administered intravenously on day 1 of each 21-day cycle for 2 cycles as part of neoadjuvant chemotherapy.

DRUGPaclitaxel+Cisplatin(Concurrent Chemoradiotherapy)

Paclitaxel (50 mg/m²) and Cisplatin (25 mg/m²) administered intravenously on days 1, 8, 15, and 22 of a 4-week cycle as part of concurrent chemoradiotherapy.

RADIATIONRadiotherapy

Radiotherapy at a dose of 40 Gy, delivered in 20 fractions over 4 weeks.


Locations(1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

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NCT06601309


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