Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma

NCT04664244 | Unknown Phase 2

• 1 other identifier: CC-NIMO1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The objective response rate includes complete and partial remission

  1 years

Secondary Outcomes (4)

• Progression-free survival

  2 years

• Overall survival

  3 years

• Disease control rate

  1 year

• Adverse event rates

  3 years

Study Arms (1)

All eligible patients

EXPERIMENTAL

All eligible patients enrolled

Combination Product: Combination of nimotuzumab and radiotherapy

Interventions

Combination of nimotuzumab and radiotherapy 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.

All eligible patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D

CONTACT

86-139-1198-8831; lileigh@163.com

Ming Wu, M.D.

CONTACT

86-138-1022-4549; wuming@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: All eligible patients will undergo the same treatment.

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 11, 2020
• Study Start: December 19, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

CN (1)