Trials / Unknown
UnknownNCT04664244
Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma
Combination of Nimotuzumab and Radiotherapy for Recurrent and Metastatic Uterine Cervical Squamous Carcinoma: a Single-arm, Open, Phase 2 Clinical Trial
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- Sponsor
- Lei Li · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-12-19
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2020-12-11
- Last updated
- 2020-12-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04664244. Inclusion in this directory is not an endorsement.