RecruitingPhase 2NCT06354140

PPIO-008 Tislelizumab Combined With S-1 in Patients With ypT+N0 ESCC After Radical Resection With Neoadjuvant STUDY

The Efficacy of Tislelizumab Combined With S-1 in Patients With Residual Primary Lesions and Node-Negative Esophageal Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy Followed by Curative Resection: A Phase II, Multicenter Trial


Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Enrollment

45 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To explore the safety and efficacy of Tegafur combined with tislelizumab in patients with esophageal squamous cell carcinoma with residual primary lesion and node-negative after radical resection following neoadjuvant immunotherapy combined with chemotherapy


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether an immunotherapy drug (tislelizumab) combined with an oral chemotherapy drug (S-1) helps patients with esophageal cancer who still have tumor cells at the primary site but no lymph node spread after surgery and pre-surgery treatment. The goal is to prevent the cancer from coming back. **You may be eligible if...** - You are 18–75 years old with esophageal squamous cell carcinoma - You received immunotherapy and chemotherapy before surgery, and after surgery your lymph nodes were clear but there was still some residual cancer at the original tumor site - You had a complete (radical) surgical removal of the tumor - You are in good physical condition (ECOG score 0 or 1) with no signs of recurrence **You may NOT be eligible if...** - You had another cancer within the past 5 years (with some exceptions) - You have had lung inflammation (interstitial lung disease) or needed steroids for pneumonia - You are currently taking systemic steroids or immune-suppressing drugs - You are severely allergic to fluorouracil chemotherapy or any monoclonal antibody - 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

DRUGTegafur

Tegafur (S-1) 80mg/100mg/120mg Q3W (discontinued at the third week) + tislelizumab 200 mg Q3W, treatment for 1 year. Tegafur: body surface area (BSA) \< 1.25m2, use 80mg; 1.25-1.5m2, use 100mg; \> 1.5m2, use 120mg. Treatment for 1 year


Locations(1)

Army Medical Center of the People's Liberation Army

Chongqing, Chongqing Municipality, China

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NCT06354140


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