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Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

Primary Purpose

Recurrent Cervical Carcinoma, Radiotherapy, Epidermal Growth Factor Receptor

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Combination of nimotuzumab and radiotherapy

About this trial

This is an interventional treatment trial for Recurrent Cervical Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Lei LiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All eligible patients

Arm Description

All eligible patients enrolled

Outcomes

Primary Outcome Measures

Objective response rate

The objective response rate includes complete and partial remission

Secondary Outcome Measures

Progression-free survival

Progression-free survival from the end of radiotherapy to the disease progression

Overall survival

Overall survival from the start of radiotherapy to the disease progression

Disease control rate

The rates of complete and partial remission, and stable disease

Adverse event rates

The rates of adverse events judged by Common Terminology Criteria for Adverse Events

Full Information

NCT ID

NCT04664244

First Posted

December 5, 2020

Last Updated

December 18, 2020

Sponsor

Lei Li

1. Study Identification

Unique Protocol Identification Number

NCT04664244

Brief Title

Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Recruiting

Study Start Date

December 19, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lei Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

All eligible patients will undergo the same treatment.

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All eligible patients

Arm Type

Experimental

Arm Description

All eligible patients enrolled

Intervention Type

Combination Product

Intervention Name(s)

Combination of nimotuzumab and radiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective response rate

Description

The objective response rate includes complete and partial remission

Time Frame

1 years

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Progression-free survival from the end of radiotherapy to the disease progression

Time Frame

2 years

Title

Overall survival

Description

Overall survival from the start of radiotherapy to the disease progression

Time Frame

3 years

Title

Disease control rate

Description

The rates of complete and partial remission, and stable disease

Time Frame

1 year

Title

Adverse event rates

Description

The rates of adverse events judged by Common Terminology Criteria for Adverse Events

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lei Li, M.D

Phone

86-139-1198-8831

lileigh@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Wu, M.D.

Phone

86-138-1022-4549

wuming@pumch.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lei Li, M.D.

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lei Li

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lei Li, MD

Phone

8613911988831

lileigh@163.com

12. IPD Sharing Statement

Learn more about this trial

Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

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