Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Jul 21, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment for older women with a specific type of cervical cancer called cervical squamous cell carcinoma. The study will evaluate how well a medication called Nimotuzumab works when combined with a type of radiation therapy known as Intensity-Modulated Radiation Therapy (IMRT). The goal is to see if this combination is effective and safe for patients aged 65 and older who have advanced stages of this cancer and either cannot tolerate chemotherapy or choose not to receive it.

To be eligible for this trial, participants must be women aged 65 or older with a confirmed diagnosis of cervical squamous cell carcinoma at a certain stage. They should have at least one measurable tumor and meet specific health criteria, meaning they should not have serious issues with their blood, heart, lungs, liver, or kidneys. Patients will receive Nimotuzumab along with radiation treatment, and they will need to agree to participate and sign consent forms. This trial is not yet recruiting participants, but it aims to contribute valuable information about treatment options for older women facing this type of cancer.

Gender

FEMALE

Eligibility criteria

• 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.