cervical cancer
Conditions
Interventions
Sponsors
Affiliated Hospital of Inner Mongolia Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. women aged 18 to 80 years; 2. Locally recurrent squamous cell carcinoma of the cervix confirmed by histology or pathology; 3. at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST); 4. KPS scores>70; 5. a life expectancy of >=3 months were applied; 6. bone marrow function (white blood cell count>=3.5x10^9/L, neutrophil count>=1.5x10^9/L, platelet count>=100x10^9/L , hemoglobin>=90g/L; 7. liver function: total bilirubin (TBIL)<=1.5 ULN, Alanine aminotransferase (ALT), Aspartate aminotransferase(AST) <=2.5 ULN, renal(serum creatinine(Cr)<=1.5 ULN; 8. patients of childbearing potential must have had a negative serum pregnancy test prior to study entry and must agree to take effective contraceptive measures during the study period and within 3 months after the last administration; 9. Sign written informed consent before the trial.
Exclusion criteria
Exclusion criteria: 1) had serious uncontrolled psychiatric illness; 2) patients with uncontrolled brain metastasis; 3) Leucopenia caused by infection, immunity and other diseases; 4) Long-term use of CYP2C8 and CYP3A4 inhibitor drugs; 5) Severe reactions after radiotherapy, such as intestinal obstruction and radiation enteritis, have occurred and can not tolerate further treatment; 6) Major organ disorders or diseases: liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc; 7) Previous hypersensitivity to paclitaxel or human albumin; 8) History of other malignancies; 9) Subjects who had received other anti-tumor treatment or other experimental drugs within 1 month before the start of treatment; 10) Subjects participating in other clinical trials at the same time; 11) Any medical condition in which subjects are not considered suitable for study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;overall survival;progression-free survival;disease-free survival;time to progression;time to failure;safety; | — |
Countries
China
Contacts
Public ContactSun Xiaoge
Affiliated Hospital of Inner Mongolia Medical University
Outcome results
None listed