Nimotuzumab Combined With Chemoradiotherapy Versus Chemoradiotherapy for Local Advanced Cervical Squamous Cell Carcinoma

Cervical Squamous Cell Carcinoma Clinical Trial

Official title:

To Investigate the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Local Advanced Cervical Squamous Cell Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04678791
• Other study ID #: M2020411
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: December 2025

Study information

• Verified date: December 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy in the treatment of local advanced cervical squamous cell carcinoma.

Description:

This study adopts a multi-center, randomized controlled, open-label clinical trial design.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 286
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged 18-75 years old;

2. Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);

3. At least one measurable lesion according to RECIST 1.1;

4. Absence of severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction and immunodeficiency, laboratory test results meet the following criteria: Hemoglobin = 90 g/L; Absolute neutrophil count = 2 × 109/L or white blood cell count = 4.0 × 109/L; Platelet count = 100 × 109/L; Aspartate aminotransferase (AST) = 2.5 × ULN Alanine aminotransferase (ALT) = 2.5 × ULN Total bilirubin = 1.5 × ULN; Serum creatinine = 1.0 × ULN;

5. ECOG score 0-2 points;

6. Expected survival = 3 months;

7. Women of childbearing potential must have a negative serum or urine HCG within 72 hours prior to enrollment (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. A pregnancy test is not required for women who have demonstrated tubal ligation);

8. No intrauterine device;

9. Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;

10. Compliance is good and informed consent is voluntarily signed.

Exclusion Criteria:

1. Cervical adenocarcinoma and rare pathological types of malignant tumors;

2. Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;

3. Ureteral obstruction, inability to place ureteral stent or pyelostomy;

4. Pregnant or lactating women;

5. Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or at risk of fistula;

6. Human immunodeficiency virus (HIV) infection;

7. Active hepatitis B (the quantitative detection result of HBV DNA exceeds the lower limit of detection), or HCV infection (the quantitative detection result of HCV RNA exceeds the lower limit of detection);

8. Patients have a serious underlying condition that precludes safe administration of trial treatment. Including but not limited to active infection requiring systemic drug therapy: decompensated heart failure (NYHA Class III and IV), unstable angina pectoris, acute myocardial infarction within 3 months prior to enrollment;

9. Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);

10. Patients with Crohn's disease and ulcerative colitis;

11. Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;

12. Patients with known hypersensitivity to Nimotuzumab or its components;

13. Patients with contraindications to cisplatin;

14. Patients with neurological or psychiatric disorders affecting cognitive ability;

15. Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;

16. Other reasons that, in the judgment of the investigator, would make the patient inappropriate for the study.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Cervical Squamous Cell Carcinoma

Intervention

Drug:
• Nimotuzumab
Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.
• Cisplatin
Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total

Radiation:
• External-beam radiation
Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.
• Brachytherapy
Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 ~ 85 Gy at point A/HRCTV D90; if the tumor diameter is = 4 cm, the cumulative dose of = 87 Gy at point A/HRCTV D90.

Locations

Country	Name	City	State
China	Peking University 3rd Hospital	Beijing	Beijng

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year progression-free survival (PFS)	The rate of patient without progress disease in 3 years after treatment	up to 3 years
Secondary	3-year overall survival (OS)	The rate of patient alive in 3 years after treatment	up to 3 years
Secondary	Complete response rate (CRR)	Percentage of subjects in this group who achieve complete response by imaging assessment from the end of treatment to disease progression.	3 months later after treatment
Secondary	Objective response rate (ORR)	The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.	3 months later after treatment
Secondary	Incidence and severity of acute adverse events	Number and grade of participants with adverse events	up to 3 months complete treatment