Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

Lei Li

Status and phase: Unknown; Phase 2

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

Treatments: Combination Product: Combination of nimotuzumab and radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04664244

CC-NIMO1

Details and patient eligibility

About

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.

Enrollment: 43 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

All eligible patients

Experimental group

Description:

All eligible patients enrolled

Treatment:

Combination Product: Combination of nimotuzumab and radiotherapy