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

Not yet recruiting

• Conditions: Cervical Squamous Cell Carcinoma
• Interventions: Drug: Nimotuzumab; Radiation: EBRT combined with brachytherapy

• Registration Number: NCT04976478
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Study First Posted: 2021-07-26
• Last Update Posted: 2021-07-26
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 125

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observation group	EBRT combined with brachytherapy	All patients will be treated with Nimotuzumab combined with radiotherapy.
observation group	Nimotuzumab	All patients will be treated with Nimotuzumab combined with radiotherapy.

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival(DFS)	up to 3 years	The rate of patient without disease in 3 years after treatment

Secondary Outcome Measures

Name	Time	Method
The change of tumor related markers	up to 3 years	the correlation of the value of SCC，Cyfra 21-1 and therapeutic effect \[The changes of serum tumor markers (such as SCC-Ag and CYFRA21-1) were observed before and after treatment\]
The change of cervical tumor	At diagnosis and before brachytherapy	the change of the volume of the cervical tumor at diagnosis and before brachytherapy
Complete response rate(CRR)	3 months later after treatment	The percentage of subjects who achieve complete response by imaging assessment from the end of the treatment to disease progression
3-year overall survival(OS)	up to 3 years	The rate of patient alive in 3 years after treatment
SAFETY	up to 3 years	Including severity of adverse events, the incidence of adverse events and serious adverse events. Adverse events should be reported and graded according to CTCAE version 5.0
Objective response rate(ORR)	3 months later treatment	The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment
QUALITY OF LIFE(QoL)	up to 3 years	Quality of life assessed by EORTC QLQ-CX 24 \[EORTC QLQ-CX 24 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 24 items\]

Trial Locations

Locations (1)

Peking University 3rd Hospital; 🇨🇳 Beijing, Beijing, China