Recurrent/metastatic cervical squamous cell carcinoma
Conditions
Interventions
experimental group:Nituzumab treatment regimen
Sponsors
Baotou Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Definitely diagnosed as cervical squamous cell carcinoma by pathology; 3. It is confirmed by pathology and/or cytology as stage IVB (FIGO 2018 staging) or first recurrence or persistent cervical cancer (persistent cervical cancer refers to: the tumor remains or progresses after the initial radiotherapy or concurrent radiotherapy and chemotherapy for at least 3 months ; The initial radiotherapy or radiotherapy and chemotherapy have been completed for more than 4 weeks, there are new and pathologically confirmed measurable lesions in the radiotherapy field), and the patient cannot receive surgery or radiotherapy; 4. According to the RECIST 1.1 standard, there is at least one measurable lesion; 5. Those who have previously received taxane + platinum combined chemotherapy have stopped the drug for at least half a year, and the radiotherapy or concurrent radiotherapy and chemotherapy have been completed for more than 3 months; 6. The patient needs to recover from the toxic and side effects (except hemoglobin reduction) of previous treatment (surgery, radiotherapy, chemotherapy, and radiotherapy) to grade 1 and below (CTCAE 5.0) 7. No serious abnormalities in hematopoietic function, abnormalities in heart, lung, liver, kidney function and immune deficiency, and the laboratory examination results meet the following standards: (1) Hemoglobin >=90g/L; (2) The absolute neutrophil count >= 2 x 10^9/L or the white blood cell count >= 4.0 x 10^9/L; (3) Platelet count >= 100 x 10^9/L; (4) Aspartate aminotransferase (AST) = 3 months; 10. Women with potential fertility were negative for serum or urine HCG within 72 hours before enrollment (postmenopausal women must be amenorrhea for at least 12 months to be considered infertile. For women who have been confirmed to have undergone tubal ligation, No pregnancy test is required); 11. Those who do not have an intrauterine device; 12. Good compliance, voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with recurrence and metastasis less than 6 months after the last administration of neoadjuvant chemotherapy or postoperative adjuvant chemotherapy; 2. Patients who had received anti-EGFR monoclonal antibody or small molecule TKI therapy or immunotherapy within 6 months before enrollment; 3. Bilateral ureteral obstruction, ureteral stent placement or pyelostomy cannot be performed; 4. Complicated rectovaginal fistula/vaginovesical fistula/uncontrolled massive vaginal bleeding or fistula risk; 5. People infected with human immunodeficiency virus (HIV); 6. Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold); 7. Has a serious underlying disease that makes it impossible to safely administer the experimental 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 the first 3 months of enrollment; 8. A history of other malignancies (except cured basal cell carcinoma of the skin); 9. People with Crohn's disease and ulcerative colitis; 10. Participating in other clinical trials or stopping clinical trials for less than 4 weeks; 11. People known to be allergic to nituzumab or its components; 12. Neurological or mental abnormalities that affect cognitive ability; 13. Patients who cannot receive endoscopic radiotherapy after the evaluation of the lesion by the investigator; 14. Other reasons for unsuitable participation in this study as judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year progression-free survival rate;Objective remission rate;Disease control rate ;2 year total survival rate;Median Overall Survival;Medina progression-free survival;living quality;security; | — |
Countries
China
Contacts
Public ContactHuang Ying
Baotou Tumor Hospital
Outcome results
None listed