A Phase 2 interventional study of Nimotuzumab with chemoradiotherapy in Esophageal Cancer, Nimotuzumab and Chemoradiotherapy, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment
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.
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's planned enrollment of 53 is below the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 387 studies on the registry; 275 are open to participants now.
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Exclusion Criteria:
Combination Product: Nimotuzumab with chemoradiotherapy
Drug page: Nimotuzumab
Radiotherapy, 40-50.4Gy/20-28f. Nimotuzumab 400mg, ivgtt, W2d. Chemotherapy, S-1, 40-60mg/m2, on BSA，orally twice daily on radiotherapy days.
R0 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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Studies of the drug tested here: Nimotuzumab
Cancer Institute and Hospital, Chinese Academy of Medical Sciences →