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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Radiotherapy, 40-50.4Gy/20-28f. Nimotuzumab 400mg, ivgtt, W2d. Chemotherapy, S-1, 40-60mg/m2, on BSA,orally twice daily on radiotherapy days.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
RECRUITINGR0 resection rate
Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm.
Time frame: 4 months after initiation of induction chemoimmunotherapy
Pathological complete response
the complete remission of all viable cancer cells in any of the specimens from surgery, including the primary site and lymph nodes
Time frame: 4 months after initiation of induction chemoimmunotherapy
Event-free survival
the time from start of induction chemo(immuno)therapy to progression, relapse, all-cause death, or the last day of follow-up
Time frame: 1 year after all treatment
Side effects during chemoradiotherpay
the time from start of chemoradiotherapy to 1 month after chemoradiotherapy
Time frame: 1 month after chemoradiotherapy
Postoperative complications
Time frame: 1 month after surgery
Overall survival
the time from start of induction chemo(immuno)therapy to all-cause death, or the last day of follow-up
Time frame: 1 year after all treatment
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