A Phase 2 interventional study of Combination of nimotuzumab and radiotherapy in Recurrent Cervical Carcinoma, Radiotherapy and Epidermal Growth Factor Receptor, sponsored by Lei Li. Status unknown at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-22.
Sponsored by Lei Li · Phase 2, Interventional, and Treatment
Patients with recurrent or metastatic uterine cervical squamous carcinoma have very poor prognosis. For eligible patients, radiotherapy remains the choice, which has the most effective impact on the survival periods. On the hand, anti-angiogenic therapy has been proved to be promising treatment for recurrent or advanced cervical carcinomas. This study aims to discover the objective response of combination therapy with nimotuzumab (an anti-epidermal growth factor receptor [EGFR] IgG1 humanized monoclonal antibody) and radiotherapy in recurrent or metastatic uterine cervical squamous carcinoma in a single-arm, open, phase 2 clinical trial. The primary endpoint is the objective response rate evaluated by imaging methods. The second endpoints are the progression-free survival and overall survival. The treatment toxicity is regarded as one the second endpoint.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 43 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Lei Li is the lead sponsor of 60 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
All eligible patients enrolled
Combination Product: Combination of nimotuzumab and radiotherapy
Patients will undergo targeted radiotherapy no more than 8 weeks, and concurrent nimotuzumab 200 mg intravenous injection every one week till the ending of radiotherapy. Then patients undergo a maintaining therapy with nimotuzumab 200 mg intravenous injection every two weeks up to one year or till the disease progresses.
Objective response rate
The objective response rate includes complete and partial remission
Time frame: 1 years
Progression-free survival
Progression-free survival from the end of radiotherapy to the disease progression
Time frame: 2 years
Overall survival
Overall survival from the start of radiotherapy to the disease progression
Time frame: 3 years
Disease control rate
The rates of complete and partial remission, and stable disease
Time frame: 1 year
Adverse event rates
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Time frame: 3 years
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Lei Li