RecruitingPhase 2NCT06410651

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma After Failure of Chemotherapy:A Phase II Study


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

53 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) who failed to induction chemo(immuno)therapy had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc. Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies. The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab and S-1 and concurrent radiotherapy for patients who are not sensitive to induction chemo(immuno)therapy.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a targeted antibody drug (nimotuzumab) to standard chemoradiation therapy helps patients with esophageal squamous cell cancer (a type of throat/food-pipe cancer) that cannot be surgically removed. These patients will have already received initial chemotherapy with or without immunotherapy. **You may be eligible if...** - You have been diagnosed with squamous cell cancer of the esophagus confirmed by biopsy - Your cancer has been assessed as stable or locally progressing after 2–4 cycles of induction chemotherapy, or surgeons have determined it cannot be removed - Your performance status and blood/organ function are within acceptable ranges **You may NOT be eligible if...** - You have another type of primary cancer - Your blood counts or organ function are too low - You have had distant spread of cancer beyond the local area 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

COMBINATION_PRODUCTNimotuzumab with chemoradiotherapy

Radiotherapy, 40-50.4Gy/20-28f. Nimotuzumab 400mg, ivgtt, W2d. Chemotherapy, S-1, 40-60mg/m2, on BSA,orally twice daily on radiotherapy days.


Locations(1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

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NCT06410651


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