Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

Sponsor

Lei Li (Other)

Overall Status

Recruiting

CT.gov ID

NCT04664244

Collaborator

(none)

Enrollment

Location

Arm

36.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

Anticipated Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All eligible patients will undergo the same treatment.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 :

Dec 19, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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

Primary Outcome Measures

Objective response rate [1 years]
The objective response rate includes complete and partial remission

Secondary Outcome Measures

Progression-free survival [2 years]
Progression-free survival from the end of radiotherapy to the disease progression
Overall survival [3 years]
Overall survival from the start of radiotherapy to the disease progression
Disease control rate [1 year]
The rates of complete and partial remission, and stable disease
Adverse event rates [3 years]
The rates of adverse events judged by Common Terminology Criteria for Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lei Li	Beijing	Beijing	China	100730

Sponsors and Collaborators

Lei Li

Investigators

Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lei Li, Professor, Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT04664244

Other Study ID Numbers:

CC-NIMO1

First Posted:

Dec 11, 2020

Last Update Posted:

Dec 22, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Nimotuzumab

Study Results

No Results Posted as of Dec 22, 2020