Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

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

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 Overview

• Status: Recruiting
• Conditions: Recurrent Cervical Carcinoma; Radiotherapy; Objective Response Rate; Overall Survival; Progression-free Survival; Epidermal Growth Factor Receptor; Nimotuzumab
• Intervention / Treatment: Combination product: Combination of nimotuzumab and radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lei Li, M.D; Phone Number: 86-139-1198-8831; Email: lileigh@163.com
• Study Contact Backup: Name: Ming Wu, M.D.; Phone Number: 86-138-1022-4549; Email: wuming@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Lei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All eligible patients; All eligible patients enrolled	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lei Li

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 5, 2020
• First Submitted That Met QC Criteria: December 5, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplasms, Squamous Cell; Carcinoma; Recurrence; Carcinoma, Squamous Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: CC-NIMO1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No