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

Peking University

Status: Not yet enrolling

Conditions: Cervical Squamous Cell Carcinoma

Treatments: Radiation: EBRT combined with brachytherapy; Drug: Nimotuzumab

Study type: Observational

Funder types: Other

Identifiers

NCT04976478

ChiECRCT20210238

Details and patient eligibility

About

To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma

Full description

This is a perspective, multi-center, open-label and single arm study.

Enrollment: 125 estimated patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

125 participants in 1 patient group

observation group

Description:

All patients will be treated with Nimotuzumab combined with radiotherapy.

Treatment:

Drug: Nimotuzumab

Radiation: EBRT combined with brachytherapy