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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
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.
400mg, by intravenous infusion once a week in 4-6 weeks.
40-60mg/m2/d,orally twice a day concurrently with radiotherapy.
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, China
Local control rate
Time frame: 1 year
Number of Participants with acute toxicities
Acute toxicities are evaluated by NCI-CTC version 5.0
Time frame: 2-3 months
R0 resection rate
The surgical procedure was radical esophagectomy after neoadjuvant therapy.
Time frame: 2-3 months
Pathological response rate
Pathological response were classified into five grades according to Mandard Tumor Regression Grade.
Time frame: 2-3 months
Tumor Response rate
Time frame: 2-3 months
Incidence of perioperative complications
During hospital stay and within the first 30 days after completion of surgery.
Time frame: 2-3 months
Overall survival
Time frame: 1 year, 2 year
Progression free survival
Time frame: 1 year, 2 year
Texture analysis of CT and/or MRI simulation in predicting tumor response rate and prognosis
Time frame: 1 year, 2 year
ctDNA in predicting tumor response rate and prognosis
Time frame: 1 year, 2 year
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