National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Location status: Recruiting
NCT Number: NCT06429839
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Beijing, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiotherapy,40-50.4Gy/20-28f. Nimotuzumab 400mg,ivgtt,W2d. Chemotherapy, S-1,40-60mg/m2, on BSA, orally twice daily on radiotherapy days.
Time frame: 4 months after initiation of induction chemoimmunotherapy
Minimal distance tumor/circumferential resection margin (CRM) > 1 mm.
Time frame: 4 months after initiation of induction chemoimmunotherapy
the complete remission of all viable cancer cells in any of the specimens from surgery, including the primary site and lymph nodes
Time frame: 1 month after chemoradiotherapy
the time from start of chemoradiotherapy to 1 month after chemoradiotherapy
Time frame: 1 month after surgery
Time frame: 1 year after all treatment
the time from start of induction chemo(immuno)therapy to all-cause death, or the last day of follow-up
Contact information is provided by the study sponsor or research team.
Guojie Feng, B.M
CONTACT
Xin Wang, Doctor
CONTACT
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Other
Nimotuzumab Concurrent With Chemoradiotherapy for Elderly or Malnourished Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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