Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

Lei Li43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Cervical Carcinoma Radiotherapy Epidermal Growth Factor Receptor

Interventions

Combination of nimotuzumab and radiotherapyCOMBINATION_PRODUCT

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Objective response rate

The objective response rate includes complete and partial remission

Time frame: 1 years

Secondary Outcomes

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