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Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

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ClinicalTrials.gov Identifier: NCT04664244
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Cervical Carcinoma Radiotherapy Epidermal Growth Factor Receptor Nimotuzumab Objective Response Rate Progression-free Survival Overall Survival Combination Product: Combination of nimotuzumab and radiotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All eligible patients will undergo the same treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Nimotuzumab and Radiotherapy for Recurrent and Metastatic Uterine Cervical Squamous Carcinoma: a Single-arm, Open, Phase 2 Clinical Trial
Actual Study Start Date : December 19, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 1 years ]
    The objective response rate includes complete and partial remission


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
    Progression-free survival from the end of radiotherapy to the disease progression

  2. Overall survival [ Time Frame: 3 years ]
    Overall survival from the start of radiotherapy to the disease progression

  3. Disease control rate [ Time Frame: 1 year ]
    The rates of complete and partial remission, and stable disease

  4. Adverse event rates [ Time Frame: 3 years ]
    The rates of adverse events judged by Common Terminology Criteria for Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664244


Contacts
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Contact: Lei Li, M.D 86-139-1198-8831 lileigh@163.com
Contact: Ming Wu, M.D. 86-138-1022-4549 wuming@pumch.cn

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    8613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital
More Information
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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04664244    
Other Study ID Numbers: CC-NIMO1
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents