RecruitingPhase 2NCT06339619

Combination Immunotherapy of Adebrelimab With Apatinib and Tegafur for Immune Rechallenge Therapy in Esophageal Squamous Cell Carcinoma

Phase II Clinical Study of Adebrelimab Combined With Apatinib and Tegafur in the Treatment of Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma That Failed First-line Immunotherapy Combined With Chemotherapy


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

32 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this single-arm study is to explore the efficacy and safety of Adebrelimab in combination with Apatinib and Tegafur for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma that has failed first-line standard treatment with PD-1 inhibitors in combination with chemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination of adebrelimab (an immunotherapy drug), apatinib (a targeted blood vessel drug), and tegafur (an oral chemotherapy) can help patients with advanced esophageal squamous cell cancer who have already tried and failed a first round of immunotherapy combined with chemotherapy. **You may be eligible if...** - You are 18 to 75 years old - You have advanced or metastatic esophageal squamous cell cancer confirmed by biopsy - Your cancer progressed or did not respond to first-line immunotherapy plus chemotherapy - Your overall health status (ECOG PS) is 0 or 1 - Your expected survival is at least 3 months - You have adequate organ (blood, liver, kidney) function - You are able to swallow oral medications **You may NOT be eligible if...** - You have been diagnosed with another cancer in the past 5 years (excluding curable types) - You have only brain-based measurable cancer lesions - You have significant bleeding tendency or uncontrolled high levels of protein in your urine - You are pregnant or of reproductive age without effective contraception 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

20mg/kg ivgtt D1 Q3W

DRUGApatinib

250mg PO QD

DRUGTegafur

dosing based on body surface area:BSA\<1.25m2,40mg; BSA=1.25~1.5m2,50mg; BSA\>1.5m2, 60mg,PO QD D1-21 Q3W


Locations(1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT06339619