RecruitingPhase 2NCT07266493

Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

A Single-arm, Open-label, Single-center Prospective Study of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma


Sponsor

Shanghai Zhongshan Hospital

Enrollment

26 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This single center, prospective, single arm clinical study aims to evaluate the clinical efficacy and safety of Envafolimab combined with albumin bound paclitaxel and carboplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of treatments given before surgery — envafolimab (an immunotherapy drug) plus albumin-bound paclitaxel and carboplatin (chemotherapy drugs) — for people with locally advanced esophageal squamous cell carcinoma (cancer of the food pipe) that is eligible for surgical removal. **You may be eligible if...** - You are 18 or older - You have esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is locally advanced (T2–T4a stage) and you are a candidate for surgery - You have not previously received any immunotherapy, chemotherapy, targeted therapy, or radiation for this cancer - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have active autoimmune disease - You have had a previous or concurrent cancer - You have had major surgery or significant trauma in the past 28 days - You have bleeding disorders or active esophageal variceal bleeding - You have significant fluid build-up in the abdomen or chest that cannot be controlled with medication - You have a known allergy to any of the study drugs 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

DRUGChemotherapy (Albumin bound paclitaxel and Carboplatin)

Albumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period.


Locations(1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

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NCT07266493


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