RecruitingPhase 2NCT07263919

Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)

A Randomized, Controlled, Multi-center Phase II/III Clinical Trial of Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma (ESCC)


Sponsor

Akeso

Enrollment

90 participants

Start Date

Dec 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, controlled, multi-center phase II/III study. All patients are resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of perioperative Cadonilimab combined with neoadjuvant chemotherapy versus neoadjuvant chemotherapy in patients with resectable 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 cadonilimab to standard chemotherapy — before and after surgery — can improve outcomes for people with a type of esophageal (food pipe) cancer called squamous cell carcinoma that can be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with esophageal squamous cell carcinoma that doctors believe can be surgically removed - Your heart, lungs, liver, and kidneys are functioning well enough to tolerate treatment - You are well enough to carry out daily activities (not severely debilitated) **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body or cannot be surgically removed - You have had another cancer in the past 5 years - You have an active autoimmune disease (where your immune system attacks your own body) - You have active hepatitis B, tuberculosis, HIV, or other serious infections - You are pregnant or breastfeeding - You have had a heart attack, unstable heart disease, or serious heart failure in the past year - You have previously received chemotherapy or immunotherapy for this cancer 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

DRUGCadonilimab (AK104)

Specified doses on specified days.

DRUGCisplatin

IV infusion; 75mg/m2

DRUGPaclitaxel

IV infusion; 175mg/m2


Locations(1)

The Second Affiliated Hospital of Air Force Medical University

Xi'an, China

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NCT07263919