Description:

Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02034968

Link:

https://clinicaltrials.gov/show/NCT02034968

Keywords:
Versions (1) ▾
  1. 7/11/19
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

July 11, 2019

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License:
Creative Commons BY 4.0
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Eligibility Stage IV Esophageal Squamous Cell Carcinoma NCT02034968

Eligibility Stage IV Esophageal Squamous Cell Carcinoma NCT02034968

Inclusion Criteria
patient who was confirmed stage iv esophageal carcinoma by pathologic histology or cytology.
males or females aged ≥18 years, < 75 years.
eastern cooperative oncology group (ecog) performance status 0-2.
life expectancy ≥12 weeks.
adequate bone marrow, renal, and liver function are required.
able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
Exclusion Criteria
any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
allergy to anti-egfr antibody.
female subjects should not be pregnant or breast-feeding.
adequate hematological function: absolute neutrophil count (anc) ≥1.5 x 109/l, and platelet count ≥100 x 109/l. adequate renal function: serum creatinine ≤ 1.5 x uln, or ≥ 50 ml/min. adequate liver function: total bilirubin < 1.5 x upper limit of normal (uln) and alanine aminotransferase (alt) and aspartate aminotransferase (ast) < 2.5 x uln in the absence of liver metastases, or < 5 x uln in case of liver metastases.
patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.