Cervical Squamous Cell Carcinoma
Conditions
Brief 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.
Detailed description
This study adopts a multi-center, randomized controlled, open-label clinical trial design.
Interventions
DRUGNimotuzumab
Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.
DRUGCisplatin
Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total
RADIATIONExternal-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.
RADIATIONBrachytherapy
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.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year progression-free survival (PFS) | up to 3 years | The rate of patient without progress disease in 3 years after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival (OS) | up to 3 years | The rate of patient alive in 3 years after treatment |
| Complete response rate (CRR) | 3 months later after treatment | Percentage of subjects in this group who achieve complete response by imaging assessment from the end of treatment to disease progression. |
| Objective response rate (ORR) | 3 months later after treatment | The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment. |
| Incidence and severity of acute adverse events | up to 3 months complete treatment | Number and grade of participants with adverse events |
Countries
China
Outcome results
None listed