Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epidermal Growth Factor Receptor | — | UNRESOLVED | — |
| Nimotuzumab | — | UNRESOLVED | — |
| Objective Response Rate | — | UNRESOLVED | — |
| Overall Survival | — | UNRESOLVED | — |
| Progression-free Survival | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
| Recurrent Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination of nimotuzumab and radiotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All eligible patients
- description
- All eligible patients enrolled
- interventionNames
- Combination Product: Combination of nimotuzumab and radiotherapy
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 1 years
- description
- The objective response rate includes complete and partial remission
Secondary outcomes (4)
- measure
- Progression-free survival
- timeFrame
- 2 years
- description
- Progression-free survival from the end of radiotherapy to the disease progression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available