RecruitingPhase 3NCT06964568

CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC

Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial


Sponsor

Fudan University

Enrollment

452 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving a PD-1 inhibitor (an immunotherapy drug) as maintenance therapy after completing chemotherapy combined with radiation is safe and effective for people with locally advanced esophageal squamous cell cancer (cancer in the esophagus/food pipe). **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma of the esophagus, confirmed by biopsy - Your cancer is locally advanced (stages T3–T4 or lymph node involvement, including possible supraclavicular lymph nodes) - You are in good general health (able to carry out daily activities) with adequate blood and organ function - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have cancer that has spread to distant organs (except supraclavicular lymph nodes) - You have serious heart, liver, or kidney problems - You have active autoimmune disease or are taking immune-suppressing medications - 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

DRUGPD-1 inhibitor

PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year.

RADIATIONUnlimited radiotherapy

Unlimited radiotherapy 50.4Gy/28Fx

DRUGTP regimen

Chemotherapy: Paclitaxel 135mg/m2 d1+cisplatin 25mg/m2 d1-3 q28d

RADIATIONTDLN-sparing radiotherapy

Tumor draining lymph nodes-sparing radiotherapy 50.4Gy/28Fx


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06964568


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