Status:
WITHDRAWN
Neoadjuvant Treatment of Nimotuzumab With Chemotherapy or Radiotherapy in Resectable Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Peking University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Esophageal cancer is one of common malignant tumors in China and esophageal squamous cell carcinoma (ESCC) is the dominant pathological type, accounting for more than 95% of all cases. One of our phas...
Eligibility Criteria
Inclusion
- Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
- Weight loss must be less than 10% in last 6 months.
- With an expected life expectancy of ≥ 12 months
- With a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment.
- With resectable disease of primary tumor in middle or lower thoracic esophagus and clinical stage Ⅱa-Ⅲ.
- With measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Without serious system dysfunction and could tolerate chemotherapy or radiotherapy.
- Patients must have normal marrow function with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×109/L，a neutrophil count of ≥2.0×109/L, , a platelet count of ≥100×109/L, a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.5 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL.
- Patients must have normal electrocardiogram results and no history of congestive heart failure.
- Women of childbearing age should voluntarily take contraceptive measures.
- Without drug addition
- Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events.
Exclusion
- Allergic to known drug
- Patients who have received prior treatment including chemotherapy, radiotherapy and surgery.
- With unresectable disease including any T4b or M1 disease.
- Without measurable or evaluable disease.
- With history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years.
- With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.
- With neurological or psychiatric abnormalities that affect cognitive.
- Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02272699
Start Date
November 1 2014
End Date
December 1 2020
Last Update
March 18 2021
Active Locations (1)
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1
Beijing Cancer Hospital & Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142