RecruitingPhase 2NCT06429839

Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients

Nimotuzumab Concurrent With Chemoradiotherapy for Elderly or Malnourished Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Study


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

55 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) 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 with a dose of 800mg per week and S-1 and concurrent radiotherapy for patients who are elderly or malnourished.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called nimotuzumab (an antibody that targets a protein called EGFR, which many cancer cells overproduce) to standard chemoradiotherapy improves outcomes in people with esophageal squamous cell cancer. Participants will also receive nutritional support as part of the study. **You may be eligible if...** - You have been diagnosed with squamous cell carcinoma of the esophagus (confirmed by biopsy) - You have not yet received any treatment for esophageal cancer - You are in generally good health (KPS score 70 or higher) - You show signs of nutritional risk (NRS-2002 score of 2 or higher) - Your blood counts, liver function, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have already received surgery, radiation, or chemotherapy for this cancer - You have another type of cancer (with limited exceptions for previously cured skin cancer or cervical carcinoma in situ) - Your cancer has spread to distant organs (such as bones, brain, lungs, or liver) - You have an active infection, significant heart or lung problems, or inflammatory bowel disease - 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

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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NCT06429839


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