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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab concurrent with chemordiotherapy followed by surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab with chemoradiotherapy | Combination Product | Radiotherapy,40-50.4Gy/20-28f. Nimotuzumab 400mg,ivgtt,W2d. Chemotherapy, S-1,40-60mg/m2, on BSA, orally twice daily on radiotherapy days. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Minimal distance tumor/circumferential resection margin (CRM) > 1 mm. | 4 months after initiation of induction chemoimmunotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months after initiation of induction chemoimmunotherapy |
| Event-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wang, Doctor | Contact | 13311583220 | beryl_wx2000@163.com | |
| Guojie Feng, B.M | Contact | 16601212285 | fenggj18243017306@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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the time from start of chemoradiotherapy to 1 month after chemoradiotherapy
| 1 month after chemoradiotherapy |
| Postoperative complications | 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 | 1 year after all treatment |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |