A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer

  • STATUS
    Recruiting
  • days left to enroll
    55
  • participants needed
    58
  • sponsor
    Chinese Academy of Medical Sciences
Updated on 28 October 2021
cancer
carcinoma
squamous cell carcinoma
definitive treatment
metastasis
chemoradiotherapy
esophageal cancer
chemotherapy regimen
blood urea nitrogen
esophagus cancer
intensity-modulated radiation therapy
unresectable esophageal cancer

Summary

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.

Details
Condition Chemoradiation, Esophageal Carcinoma, oesophageal carcinoma, esophagus cancer, Esophageal Diseases, Esophageal Cancer, Head and Neck Cancer, head and neck cancer, Unresectable Malignant Neoplasm, oesophageal cancer, cancer of the esophagus, Chemoradiotherapy, Nimotuzumab, Chemotherapy, Esophageal Disorders
Treatment Radiotherapy, S-1, Nimotuzumab
Clinical Study IdentifierNCT04207918
SponsorChinese Academy of Medical Sciences
Last Modified on28 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years
Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis)
Primary treatment accepted in Chinese Academy of Medical Sciences
KPS 70
NRS score 2
Cervical or thoracic esophageal cancer histologically proved esophageal cell carcinoma
Normal organ and marrow function as defined below
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
Informed consent

Exclusion Criteria

Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
Any prior chemotherapy or other cancer treatment prior to this protocol
With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation
History of allergic reactions attributed to contrast medium, similar chemical or biologic complex
Existing esophageal fistula, perforation and cachexia
Existing active infection such as active tuberculosis and hepatitis
Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
Participation in other clinical trials currently or within 4 weeks of selection
Pregnant or lactating females
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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