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This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Chemoradiotherapy（NCRT） | Experimental | NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | 44.94Gy and 37.8Gy in 21 fractions to PGTV and PTV for neoadjuvant treatment. 59.92Gy and 50.4Gy in 28 fractions to PGTV and PTV for definitive treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with acute toxicities | Acute toxicities are evaluated by NCI-CTC version 5.0 | 2-3 months |
| R0 resection rate | The surgical procedure was radical esophagectomy after neoadjuvant therapy. |
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Inclusion Criteria:
Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 3,500 G/L; Neutrophil: greater than or equal to 1,500 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine within normal upper limits; BUN within normal upper limits; AST/ALT: less than or equal to 1.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; Alkaline phosphatase :less than or equal to 1.5 times the upper limit
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Beijing | 100021 | 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 |
|---|---|
| D011878 | Radiotherapy |
| C501466 | nimotuzumab |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Nimotuzumab | Drug | 400mg, by intravenous infusion once a week in 4-6 weeks. |
|
| S-1 | Drug | 40-60mg/m2/d，orally twice a day concurrently with radiotherapy. |
|
| 2-3 months |
| Pathological response rate | Pathological response were classified into five grades according to Mandard Tumor Regression Grade. | 2-3 months |
| Tumor Response rate | 2-3 months |
| Incidence of perioperative complications | During hospital stay and within the first 30 days after completion of surgery. | 2-3 months |
| Overall survival | 1 year, 2 year |
| Progression free survival | 1 year, 2 year |
| Texture analysis of CT and/or MRI simulation in predicting tumor response rate and prognosis | 1 year, 2 year |
| ctDNA in predicting tumor response rate and prognosis | 1 year, 2 year |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |