Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Combination of Nimotuzumab and Radiotherapy for Recurrent and Metastatic Uterine Cervical Squamous Carcinoma: a Single-arm, Open, Phase 2 Clinical Trial

Conditions
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Recurrent Cervical Carcinoma, Radiotherapy, Epidermal Growth Factor Receptor, Nimotuzumab, Objective Response Rate, Progression-free Survival, Overall Survival

Intervention / Treatment
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* Combination Product: Combination of nimotuzumab and radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged more than 18 years Eastern Cooperative Oncology Group score 0-1 Pathological confirmed of uterine cervical squamous carcinoma An interval of 3 months or more since the fulfilling of last treatment At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1 Anticipative survival period of 3 months or more Lab testing within reference ranges With appropriate contraception Provided consents of participating the trial Exclusion Criteria: With a history of exposure to other antiangiogenic agents With other malignancies within past 3 years With vital complications With uncontrolled hypertension despite of medical treatment With brain metastasis With addiction to psychiatric medications or with mental disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All eligible patients will undergo the same treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All eligible patients<br>All eligible patients enrolled | Combination Product: Combination of nimotuzumab and radiotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | The objective response rate includes complete and partial remission | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival from the end of radiotherapy to the disease progression | 2 years | 
| Overall survival | Overall survival from the start of radiotherapy to the disease progression | 3 years | 
| Disease control rate | The rates of complete and partial remission, and stable disease | 1 year | 
| Adverse event rates | The rates of adverse events judged by Common Terminology Criteria for Adverse Events | 3 years |