Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

Radiotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04664244
• Other study ID #: CC-NIMO1
• Status: Recruiting
• Phase: Phase 2
• Start date: December 19, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2020
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D
• Phone: 86-139-1198-8831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	The objective response rate includes complete and partial remission	1 years
Secondary	Progression-free survival	Progression-free survival from the end of radiotherapy to the disease progression	2 years
Secondary	Overall survival	Overall survival from the start of radiotherapy to the disease progression	3 years
Secondary	Disease control rate	The rates of complete and partial remission, and stable disease	1 year
Secondary	Adverse event rates	The rates of adverse events judged by Common Terminology Criteria for Adverse Events	3 years