Cervical cancer
Conditions
Interventions
One:nituzumab combined with concurrent chemoradiotherapy
Sponsors
Beidahuang Group General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years; 2. Initial treatment of cervical squamous cell carcinoma diagnosed histologically, clinical stage IB3-IVA (FIGO 2018 stage); 3. At least one measurable lesion according to RECIST 1.1; 4. No serious hematopoietic dysfunction, abnormal heart, lung, liver or kidney function and immune deficiency, and the laboratory examination results meet the following criteria: (1) Hemoglobin >= 90g/L; (2) Neutrophil absolute count >= 2 x 10^9/L or white blood cell count >= 4.0 x 10^9/L; (3) Platelet count >= 100 x 10^9/L; (4) Aspartate aminotransferase (AST) = 3 months; 7. Women with potential fertility were serum or urinary HCG negative within 72 hours prior to enrollment (postmenopausal women must have been amenorrhea for at least 12 months to be considered infertile. Pregnancy tests are not required for women who have a proven tubal ligation); 8. People without iUD; 9. The willingness of potentially fertile women to use medically approved contraceptive methods during the trial; 10.Good compliance, voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Cervical adenocarcinoma and rare pathological malignancy; 2. Previous surgical treatment for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy; 3. Patients with bilateral ureteral obstruction, unable to implant ureteral stents or perform pyelostomy; 4. Pregnant or lactating; 5. Patients with rectovaginal fistula/vagino-bladder fistula/uncontrolled vaginal bleeding or at risk of fistula; 6. People infected with human immunodeficiency virus (HIV); 7. Active hepatitis B (HBV DNA quantitative test results exceed the lower limit), or HCV infection (HCV RNA quantitative test results exceed the lower limit); 8. Have a serious underlying medical condition that makes it impossible to safely administer the trial treatment. Including but not limited to active infections requiring systemic medication: compensatory heart failure (NYHA grade III and IV), unstable angina, and acute myocardial infarction within 3 months prior to enrollment; 9. Have a history of other malignant tumors (except cured basal cell carcinoma of the skin); 10. Patients with Crohn's disease and ulcerative colitis; 11. Participating in other clinical trials or have stopped clinical trials for less than 4 weeks; 12. Known allergy to nituzumab or its components; 13. Patients with contraindications to cisplatin; 14. Neurological or psychiatric disorders that affect cognitive ability; 15. Patients whose lesions were evaluated by the investigator and were unable to undergo endovascular radiation therapy; 16. Other reasons not suitable for participation in this study were determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging examination;3-year progresion-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival;complete remission rate;overall response rate;safety; | — |
Countries
China
Contacts
Public ContactLv Lili
Beidahuang Group General Hospital
Outcome results
None listed