Clinical trial NCT04976478: Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
Official title: A Perspective, Multi-center, Single Arm Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Squamous Cell Carcinoma
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 125
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The elder patients with cervical squamous cell cancer received nimotuzumab combined with radiotherapy.

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

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

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.

Primary outcomes:
measure: 3-year disease-free survival(DFS)
timeFrame: up to 3 years
Secondary outcomes:
measure: Complete response rate(CRR)
timeFrame: 3 months later after treatment
measure: Objective response rate(ORR)
timeFrame: 3 months later treatment
measure: 3-year overall survival(OS)
timeFrame: up to 3 years
measure: The change of tumor related markers
timeFrame: up to 3 years
measure: The change of cervical tumor
timeFrame: At diagnosis and before brachytherapy
measure: QUALITY OF LIFE(QoL)
timeFrame: up to 3 years
measure: SAFETY
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University 3rd Hospital
state: Beijing
Study officials:
References: