Recurrent Cervical CarcinomaPhase 2NCT04664244
Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma
A Phase 2 study testing Combination of nimotuzumab and radiotherapy in people with Recurrent Cervical Carcinoma and Radiotherapy, run by Lei Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Cervical Carcinoma, Radiotherapy, Epidermal Growth Factor Receptor
- What is being tested?
- Combination of nimotuzumab and radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2020to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Lab testing within reference ranges
- With appropriate contraception
- Provided consents of participating the trial
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 8613911988831, lileigh@163.com
About this study
Official title: Combination of Nimotuzumab and Radiotherapy for Recurrent and Metastatic Uterine Cervical Squamous Carcinoma: a Single-arm, Open, Phase 2 Clinical Trial
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
- Being tested
- Combination of nimotuzumab and radiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of nimotuzumab and radiotherapyCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| All eligible patients | Experimental | All eligible patients enrolled Receives: Combination Product: Combination of nimotuzumab and radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The objective response rate includes complete and partial remission
Measured: 1 years
Secondary outcomes (4)
Progression-free survival
Progression-free survival from the end of radiotherapy to the disease progression
Measured: 2 years
Overall survival
Overall survival from the start of radiotherapy to the disease progression
Measured: 3 years
Disease control rate
The rates of complete and partial remission, and stable disease
Measured: 1 year
Adverse event rates
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start19 Dec 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible patients will undergo the same treatment.
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664244
- Sponsor's protocol ID
- CC-NIMO1
- Status last verified
- Dec 2020
- First submitted
- 5 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Nimotuzumab and Radiotherapy for Recurrent and Metastatic Uterine Cervical Squamous Carcinoma: a Single-arm, Open, Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT04664244
- Acronym / sponsor ID
- CC-NIMO1
- Conditions
- Recurrent Cervical Carcinoma, Radiotherapy, Epidermal Growth Factor Receptor, Nimotuzumab, Objective Response Rate, Progression-free Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 19 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible patients will undergo the same treatment.
| Arm | Type | Receives |
|---|---|---|
| All eligible patients | Experimental | Combination Product: Combination of nimotuzumab and radiotherapyAll eligible patients enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of nimotuzumab and radiotherapyPatients 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. | Combination product | All eligible patients |
Primary outcome
Objective response rate
Time frame: 1 years
The objective response rate includes complete and partial remission
4 secondary outcomes
Progression-free survival
Time frame: 2 years
Overall survival
Time frame: 3 years
Disease control rate
Time frame: 1 year
Adverse event rates
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination of nimotuzumab and radiotherapy in people with Recurrent Cervical Carcinoma and Radiotherapy, run by Lei Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, M.D (86-139-1198-8831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.