Endometrial cancer
Conditions
Interventions
Single arm group:Androtinib hydrochloride
Sponsors
Liuzhou Workers' Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Those who met all of the following inclusion criteria were enrolled in this trial: 1.Subjects volunteered to join this trial and signed informed consent; 2.Age >= 18 years (at time of signing informed consent); ECOG PS score: 0-1 points; Expected survival greater than 3 months; 3.Recurrent or advanced endometrial cancer has received at least one previous line of systemic chemotherapy with platinum containing regimens; 4.Confirmed by RECIST 1.1 criteria with at least one measurable lesion; 5.The damage caused by other treatments was restored(NCI-CTCAE 4.0 grade=90 g/L; 2)Absolute neutrophil count (NEUT) >= 1.5x10^9/L; 3)Platelet count (PLT) >= 90 x 10^9/ L (2)Biochemical tests were required to meet the following criteria: 1)Total bilirubin (TBIL) = 60mL / min; (3)Coagulation or thyroid function tests were required to meet the following criteria: 1)Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) <= 1.5xULM (No anticoagulant therapy has been received.); 2)Thyroid stimulating hormone (TSH) <= ULN; enrolled if abnormal should be investigated for T3 and T4 levels, which are normal. (4)Color Doppler echocardiography: left ventricular ejection fraction (LVEF) was greater than 50%. 7.Female subjects of childbearing age should agree that they must be using contraception (such as intrauterine devices or condoms) during the study and for 6 months after the end of the study, have a negative serum pregnancy test within 7 days before study entry, and must be non lactating subjects.
Exclusion criteria
Exclusion criteria: 1.Comorbid diseases and medical history (1)Had developed or currently had concurrent other malignancies within 3 years.Patients could be enrolled if two of the following: other malignancies treated by a single operation, achieving a continuous 5-year disease-free survival (DFS), cured carcinoma in situ of the uterine cervix, cutaneous cancer not melanoma and superficial bladder tumours [ta (non-invasive tumour), tis (carcinoma in situ) and T1 (tumour infiltrating basement membrane)]; (2)Pathology suggested uterine sarcoma, such as carcinosarcoma (mixed malignant mullerian tumor), endometrial leiomyosarcoma, endometrial stromal sarcoma, or other high-grade sarcoma; (3)Having multiple factors affecting oral medications (e.g., inability to swallow, chronic diarrhea, and ileus); (4)Non remitting toxicities above CTC AE grade 1 due to any previous antitumour therapy, excluding alopecia; (5)Had received major surgical treatment, incisional biopsy, etc., within 28 days prior to the start of study treatment; (6)Long-standing incurable wounds or fractures; (7)Had an arterio / venous thrombotic / carcinothrombotic event within 6 months, such as cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; (8)Uncontrolled, pleural effusion still requiring repeated drainage, pericardial effusion or ascites (investigator judgment); (9)Those with a history of substance abuse who are unable to abstain from or have a psychotic disorder; (10)Presence of any subjects with severe and / or uncontrolled disease, including: 1)Blood pressure control is not ideal(systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); 2)Patients with >= grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including QTc >= 450 ms (in men) and QTc >= 470 MS (in women)) and >= grade 2 congestive heart failure (New York Heart Association (NYHA) class); 3)Active or uncontrolled serious infection (>= CTC AE grade 2 infection); 4)Current presence of CTCAE 5.0 >= 2 pneumonia; 5)Cirrhosis, active hepatitis*; *Note: active hepatitis (hepatitis B reference: HBsAg positive (> 1 x 10^3 copies / mL or > 2000 IU / mL); hepatitis C reference: HCV antibody positive with an HCV viral titer test above the upper limit of normal). 6)Those with renal failure requiring hemodialysis or peritoneal dialysis; 7)Had a history of immunodeficiency, including HIV positive or with other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 8)Poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol / L); 9)Urine routine was suggestive of proteinuria >= ++, and confirmed by 24-hour urine protein quantification > 1.0 g; 10)Patients with epilepsy and need for treatment; 2.Tumor related symptoms and treatment: (1)Had received surgery, chemotherapy, radiotherapy, or other anticancer therapy within 4 weeks before the start of study treatment (washout period was calculated from the end of last dose of treatment).Orally targeted agents have less than 5 drug half lives.Had received previous local radiotherapy and could be enrolled if the following conditions were met: the end of radiotherapy was more than 4 weeks from the start of study treatment (more than 2 weeks for radiotherapy to the brain); and the target lesion selected for this study was not within the radiotherapy field; or the target lesion was within the radiotherap
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactChen Guowei, Wei Luwei
Liuzhou Workers' Hospital
Outcome results
None listed