Advanced, recurrent, and persistent vaginal cancer, cervical cancer, and uterine malignancies
Conditions
Interventions
Group 1:Anlotinib Hydrochloride group+chemotherapy
Sponsors
Shandong Provincial Cancer Hospital affiliated to Shandong University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years; 2. ECOG PS 0-2 points; 3. Cervical cancer diagnosed by pathology; 4. Subjects received damage from other treatments (NCI-CTCAE version 4.0 grade =1), including surgery = 4 weeks; EGFR TKI class molecular targeted drugs = 2 weeks; 5. Baseline blood and biochemical indicators meet the following criteria: Hemoglobin =90g/L; Absolute neutrophil count (ANC) =1.5×10^9/L; Platelet =80×10^9/L; ALT, AST=2.5×ULN; =5×ULN (with liver metastasis); Serum total bilirubin = 1.5 × ULN; Serum creatinine = 1.5 × ULN or endogenous creatinine clearance = 45 ml/min (Cockcroft-Gault formula); 6. The survival period to be estimated longer than 3 months; 7. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: 1. A person who has been confirmed to be allergic to Anlotinib Hydrochloride and/or its excipients; 2. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 3. Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval = 470 ms); according to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac ultrasound Check for a left ventricular ejection fraction (LVEF) <50%; 4. Patients with positive urine protein; 5. Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 6. Patients with a clear tendency to gastrointestinal bleeding, including the following conditions: local active ulcer lesions, fecal occult blood (++) can not be included; 2 months of hospitable, hematemesis history; 7. Abnormal blood coagulation, or known hereditary or acquired bleeding tendency and tendency to thrombosis; 8. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment; 9. Accompanied by central nervous system metastasis; 10. Pregnant or lactating women; 11. Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 12. Patients who have participated in other drug clinical trials within 4 weeks; 13. Have received VEGFR inhibitors such as sorafenib and sunitinib; 14. The investigator determines other conditions that may affect the conduct of the clinical study and the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;TTP; | — |
Countries
China
Contacts
Public ContactJinming Yu
Shandong Provincial Cancer Hospital affiliated to Shandong University
Outcome results
None listed