Clinical trial · Observational
Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
NCT04976478CI-TRIAL-00052896not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBRT combined with brachytherapy | Radiation | — | UNRESOLVED |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- observation group
- description
- All patients will be treated with Nimotuzumab combined with radiotherapy.
- interventionNames
- Drug: Nimotuzumab
- Radiation: EBRT combined with brachytherapy
Primary outcomes (1)
- measure
- 3-year disease-free survival(DFS)
- timeFrame
- up to 3 years
- description
- The rate of patient without disease in 3 years after treatment
Secondary outcomes (7)
- measure
- Complete response rate(CRR)
- timeFrame
- 3 months later after treatment
- description
- The percentage of subjects who achieve complete response by imaging assessment from the end of the treatment to disease progression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age≥65 years old 2. Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018) 3. At least one measurable lesion according to RECIST 1.1 guideline 4. Patients are intolerant to or refuse chemotherapy. 5. No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria: Hemoglobin ≥90g/L Absolute count of neutrophils≥2×109/L orwhite blood cell count≥4.0×109/L; Platelet count≥100×109/L; AST≤2.5×ULN ALT≤2.5×ULN TBIL≤1.5×ULN; Serum creatinine≤1.5×ULN or CrCl\> 60 mL/min(according toCockcroft-Gault): Serum creatinine≤1.5×ULN Female CrCl=(140-Age)×Weight(kg)×0.85 / (72×Scr mg/dl) 6. ECOG score 0-2 7. Expectancy of life is at least 3 months. 8. Eligible for pelvic MRI examination. 9. The patients voluntarily received nimotuzumab combined with radiotherapy. 10. Patients can comply with the protocol and are willing to sign informed consent. Exclusion Criteria: 1. Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy 2. Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy. 3. Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or with fistula risk. .4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment. 7)Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin. 8)Patients with Crohn's disease and ulcerative colitis. 9)Patients are allergic to Nimotuzumab or its compounds. 10)Patients with neurological or psychiatric abnormalities that affect cognitive ability. 11)Intracavitary brachytherapy cannot be performed that was assessed by the investigator. 12)Other factors were assessed by investigators to be unsuitable to this study.
References
Publications (0)
Data not yet available
No reference posted for this study.