RecruitingPhase 2NCT07457528

Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC

Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

46 participants

Start Date

Mar 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is conducted in patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 46 patients with resectable locally advanced esophageal cancer in Tianjin cancer hospital. Patients will be treated with serplulimab, nimotuzumab plus concurrent chemoradiotherapy (41.4Gy/1.8Gy/23F) . Six to eight weeks after the completion of neoadjuvant chemoradiotherapy, patients who are considered operable by surgeons will undergo radical resection of esophageal cancer. Postoperative pathological assessment includes MPR rate, pCR rate, and pathological response grade, etc. This trial aims to explore the safety and efficacy of adding serplulimab and nimotuzumab to neoadjuvant chemoradiotherapy, with a focus on whether the combined treatment regimen can enhance the efficacy and safety of neoadjuvant chemoradiotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of immunotherapy drugs (serplulimab and nimotuzumab) added to standard pre-surgery chemoradiation for patients with locally advanced esophageal squamous cell cancer (a cancer of the food pipe) that can potentially be removed with surgery. The hope is that adding these immune-boosting drugs will improve how much the cancer shrinks before surgery and lead to better long-term outcomes. **You may be eligible if...** - You are between 18 and 75 years old with confirmed esophageal squamous cell cancer at a locally advanced stage - You have not received any prior treatment for this cancer - Your cancer is expected to be completely removable by surgery - You have no evidence of spread to distant organs - Your organ function (blood counts, liver, kidneys, heart, lungs) meets the required minimum levels **You may NOT be eligible if...** - You have received EGFR-targeted drugs in the past 6 months - You have serious heart failure, uncontrolled high blood pressure, renal failure, severe diabetes, or mental disorders - You have brain metastases with symptoms - You have had another cancer in the past 5 years (with some exceptions) - 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

DRUGHLX10

Serplulimab 300mg d1, d22

DRUGChemotherapy

Albumin-paclitaxel 175mg/m², carboplatin AUC = 4-5, d1, d22

DRUGNimotuzumab

Nimotuzumab 400mg d1, qw, total of 5 cycles


Locations(1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

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NCT07457528


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