Epidermal Growth Factor Receptor, Nimotuzumab, Objective Response Rate, Overall Survival, Progression-free Survival, Radiotherapy, Recurrent Cervical Carcinoma
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTCombination 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.
Sponsors
Lei Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All eligible patients will undergo the same treatment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 1 years | The objective response rate includes complete and partial remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 years | Progression-free survival from the end of radiotherapy to the disease progression |
| Overall survival | 3 years | Overall survival from the start of radiotherapy to the disease progression |
| Disease control rate | 1 year | The rates of complete and partial remission, and stable disease |
| Adverse event rates | 3 years | The rates of adverse events judged by Common Terminology Criteria for Adverse Events |
Countries
China
Contacts
Primary ContactLei Li, M.D
Backup ContactMing Wu, M.D.
Outcome results
None listed