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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04678791
Other study ID # M2020411
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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