Nimotuzumab for Recurrent Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    67
  • sponsor
    Fujian Cancer Hospital
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Updated on 14 February 2022
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Summary

The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer.

Description

The clinical efficacy of Nimotuzumab combined with radiotherapy has been shown in advanced nasopharyngeal cancer, which was significantly higher than radiotherapy alone. The efficacy of radiotherapy combined with Nimotuzumab has not been confirmed in recurrent nasopharyngeal cancer.In this study, Phase II clinical trials were performed. The patients were treated with Nimotuzumab which were used concurrently with IMRT. The efficacy and toxicity will be assessed.

Details
Condition Recurrent Nasopharyngeal Carcinoma
Treatment Nimotuzumab
Clinical Study IdentifierNCT03666221
SponsorFujian Cancer Hospital
Last Modified on14 February 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment
Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations
Age 18-70
At least one of the tumor lesions measurable
Functional Status: PS (ECOG) > 0-1
Normal Bone Marrow Function: White blood cell count > 4109/L, hemoglobin >90g/L, and platelet count >100109/L
Normal Hepatic and Renal Function: Alanine Tminotransferase (ALT)/Aspartate Aminotransferase (AST) < 2.5 times the upper limit of normal (ULN), while total bilirubin (T-Bil) < 1.5 x ULN and serum creatinine < 1.5 x ULN
Life expectancy of more than 6 months
All the patients signed the informed consent
Follow up regularly and comply with test requirements

Exclusion Criteria

Patients with recurrent cervical lymph nodes alone
Evidence of distant metastasis
The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy
Creatinine clearance < 30ml/min
Has received epidermal growth factor targeting therapy
Second malignancy within 5 years(except of Non-melanoma Skin Cancer or carcinoma in situ of cervix)
Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc
Active systemic infection
History of Serious lung or heart disease
Drug or alcohol addiction
Persons without capacity for civil conduct or persons with limited capacity for civil conduct
The patient has physical or mental disorders and is believed to be unable to fully or fully understand the possible complications of the study
To receive chronic systemic immunotherapy or hormone therapy other than this study
Women who are pregnant or breast feeding
Participation in other drugs clinical trials within 1 month
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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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