Malignant uterine tumor
Conditions
Interventions
Case series:Apatinib
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18 -70 years old female; 2. ECOG score 0 to 1; 3. The expected survival time is more than 3 months; 4. Recurrent malignant uterine tumors confirmed by histology and pathology, pathological types include: Endometrial carcinoma (Endometrioid carcinoma,Serous papillary carcinoma, Clear cell carcinoma, Undifferentiated carcinoma, Neuroendocrine carcinoma, Squamous cell carcinoma, etc), Uterine carcinosarcoma, Uterine leiomyosarcoma, High-grade endometrial stromal sarcoma, Uterine adenosarcoma, etc.; 5. Received at least two line chemotherapy regimens, and meet the following definition of treatment failure: The interval between the second-line regimen and the above treatment, or the subsequent disease progression, and the last treatment was less than 3 months; 6. According to RECIST 1.1 edition, at least one extracranial measurable lesion is available; 7. No radiotherapy was received within 4 weeks prior to the start of the study; 8. The main organ function, which meet the following criteria:Blood routine: Hb > 90 g/L (no blood transfusion within 14 days); ANC =1.5×10^9/L; PLT =75×10^9/L; Liver function: total bilirubin TBIL = 1. 5 × ULN (upper limit);ALT and AST = 3 × ULN; If there is liver metastasis, ALT and AST = 5×ULN; Renal function: serum Cris= 1×ULN; 9. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: 1. Histological pathology was low-grade endometrial stromal sarcoma; history of other malignant tumors in the past 5 years, except for cured skin basal cell carcinoma and cervical in situ; 2. Participated in clinical trials of unlisted drugs within 4 weeks prior to the start of the study; previously used VEGFR inhibitors (allowed use of bevacizumab); 3. Symptomatic central system metastasis. For stable non-brain metastasis clinically relevant symptoms for at least 8 weeks, and no need for glucocorticoid drugs and mannitol to reduce intracranial pressure before the start of the study; and at least one other site of evaluable target lesions other than brain metastases can be admitted Group, those who received brain radiotherapy should be separated from the last radiotherapy time by more than four weeks; 4. Severe cardiopulmonary insufficiency, severe liver and kidney dysfunction; severe or uncontrolled infection; long-term unhealed wounds or fractures; 5. Patients with hypertension who cannot get good control through antihypertensive drug therapy (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg), patients with myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QT interval > 440 ms) or cardiac insufficiency; 6. Multiple factors that affect the oral and absorption of drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea, and intestinal obstruction); 7. Abnormal coagulation function (PT > 16s, APTT > 43s, TT > 21s, Fbg < 2 g/L), being treated with thrombolysis or anticoagulation, having bleeding tendency, or having definite gastrointestinal bleeding concern (e.g., having local active ulcer lesions, fecal occult blood ++); 8. Overactive/venous thrombosis occurred within 6 months prior to the start of the study, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, PFS; | — |
Countries
China
Contacts
Public ContactYulan Ren
Fudan University Shanghai Cancer Center
Outcome results
None listed