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Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

NCT ID: NCT04664244

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-19

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All eligible patients will undergo the same treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All eligible patients

All eligible patients enrolled

Group Type EXPERIMENTAL

Combination of nimotuzumab and radiotherapy

Intervention Type COMBINATION_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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D

Role: CONTACT

Phone: 86-139-1198-8831

Email: [email protected]

Ming Wu, M.D.

Role: CONTACT

Phone: 86-138-1022-4549

Email: [email protected]

Facility Contacts

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Lei Li, MD

Role: primary

Other Identifiers

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CC-NIMO1

Identifier Type: -

Identifier Source: org_study_id