Cervical carcinoma
Conditions
Interventions
Nituzumab combined chemotherapy group:Nituzumab combined chemotherapy group
Sponsors
Chifeng hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. Primary cervical squamous cell carcinoma diagnosed by histology; 3. It is confirmed by imaging that it is the first treatment patient in IB IVA stage (FIGO 2018 stage), which cannot accept surgery and needs radical radiotherapy; 4. At least one measurable lesion according to RECIST 1.1 criteria; 5. There is no serious hematopoietic dysfunction, heart, lung, liver and kidney dysfunction and immune deficiency. The laboratory test results meet the following standards: (1) Hemoglobin >=90g/L; (2) Absolute neutrophil count >=2X10^9/L or leukocyte count >=4.0*10^9/L; (3) Platelet count >=100x10^9/L; (4) Aspartate aminotransferase (AST) =6 months; 8. Women with potential fertility are negative for serum or urinary HCG within 72 hours before enrollment (postmenopausal women must have amenorrhea for at least 12 months and are considered infertile. Pregnancy tests are not required for women who have been confirmed to have undergone tubal ligation); 9. Good compliance, voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. Bilateral ureteral obstruction, unable to place ureteral stent or pyelostomy; 2. Patients with rectovaginal fistula/vaginal bladder fistula / uncontrolled vaginal bleeding or risk of fistula; 3. People infected with human immunodeficiency virus (HIV); 4. Active hepatitis B (HBV DNA quantitative test result exceeds the lower limit of detection), or HCV infection (HCV RNA quantitative test result exceeds the lower limit of detection); 5. Suffering from serious basic diseases, which makes it impossible to safely give trial treatment. Including but not limited to active infections requiring systemic medication: negligent compensatory heart failure (NYHA grade III and IV), unstable angina pectoris and acute myocardial infarction within 3 months before enrollment; 6. Patients with a history of other malignant tumors (except cured skin basal cell carcinoma); 7. Patients with Crohn's disease and ulcerative colitis; 8. Participating in other clinical trials or stopping clinical trials for less than 4 weeks; 9. Known allergy to nituzumab or its components; 10. Neurological or mental abnormalities affecting cognitive ability; 11. Those who cannot receive intraluminal radiotherapy after the investigator's evaluation of the focus; 12. According to the judgment of the researcher, there are other reasons that are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Objective tumor response rate;Quality of life;Security; | — |
Countries
China
Contacts
Public ContactWu Di
Chifeng hospital
Outcome results
None listed