Urothelial carcinoma
Conditions
Sponsors
Yanbian University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in the study and signed the informed consent; 2. No gender limitis,and aged >= 18 years; 3. Patients diagnosed with advanced urothelial carcinoma by pathology or cytology (refer to the first pathological results); 4. Disease progression after previous first-line chemotherapy; 5. According to RECIST version 1.1, there must be at least one measurable lesion; 6. ECOG score: 0-1; 7. Expected survival >=12 weeks; 8. Major organ function meets the following requirements (within 7 days prior to initiation of study treatment): (1) Routine blood examination (except hemoglobin, no blood transfusion, no use of granulocyte colony stimulating factor [G-CSF], no use of drug correction within 14 days before screening): absolute neutrophils count >=1.5 x 10^9/L, platelet >= 75 x 10^9/L, hemoglobin >= 90 g/L; (2) Biochemical examination (no albumin infusion within 14 days before screening):serum albumin >= 29 g/L, serum total bilirubin 50 mL/min (Cockcroft-Gault formula follows): male: CR clearance =((140- age)x weight)/(72 x blood CR) female: CR clearance rate =((140- age)x weight)/(72 x blood CR)x 0.85 weight unit: Kg; Blood Cr unit: mg/mL; (3) International standardized ratio (INR) = 2+, 24-hour (h) urine protein quantification can be performed, and 24h urine protein quantification = 12 months, no cause other than menopause found) and has not undergone sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). 10. For male patients whose partner is a woman of childbearing age, they must agree to abstain from sex or use a reliable, effective method of contraception for at least 120 days from the date of signing an informed consent until the last dint of the study drug. Male subjects also had to agree not to donate sperm during the same period. Male subjects whose partners are pregnant should use condoms and no other method of contraception is required.
Exclusion criteria
Exclusion criteria: 1. Patients who are preparing for or have previously received an organ or allogeneic bone marrow transplant; 2. Patients with active brain metastases identified by pre-screening and imaging evaluation; 3. With a history of gastrointestinal bleeding or a gastrointestinal bleeding tendency within 6 months before the research and treatment, such as: there is a risk of hemorrhage or severe esophageal gastric varices, any local activity of the digestive tract ulcer lesions and continuous defecate occult blood positive shall not enter into the group (baseline period if defecate occult blood positive, can review, after review if still positive, gastroduodenal microscopy (or EGD) is required, if or EGD hint of esophageal gastric varices bleeding risk is not into the group); 4. With abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 6 months prior to study treatment; 5. With known hereditary or acquired bleeding (e.g., coagulation dysfunction) or thrombotic tendencies, such as hemophilia, or currently or recently (within 10 days prior to the commencement of study treatment) using a full dose of an oral or injected anticoagulant or thrombolytic drug for therapeutic purposes (allowing prophylactic use of low-dose aspirin, low-molecular weight heparin); 6. Current use or recent use (within 10 days prior to study treatment initiation) of aspirin (> 325 mg/ day (maximum anti-platelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilotazole; 7. With thrombosis or embolism events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the study treatment; 8. Have not well controlled cardiac clinical symptoms or diseases, such as: (1) According to the New York Heart Association (NYHA) standards (see Annex 5) class II or above cardiac dysfunction or cardiac color ultrasound examination: LVEF (left ventricular ejection fraction) 450ms (male)or QTc > 470ms (female) (QTc interval calculated by Fridericia formula. If QTC is abnormal, it can be detected continuously for three times at an interval of 2 minutes, and the average value is taken); 9. Have hypertension that is not well controlled by antihypertensive medication (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg) (based on the mean of BP readings from >= 2 measurements)(Using antihypertensive therapy to achieve the above parameters is allowed) or with previous hypertensive crisis or hypertensive encephalopathy; 10. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral artery thrombosis) occurred within 6 months prior to study treatment initiation; 11. Severe, unhealed or open wounds and active ulcers or untreated fractures; 12. Underwent major surgery (other than diagnosis) within 4 weeks prior to the start of study treatment or was expected to undergo major surgery during the study period; 13. Inability to swallow pills; 14. A history of intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to the commencement of study treatment, including incomplete obstruction related
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease-free survival;Duration of relief;Disease control rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactPiao Longzhen
Yanbian University Hospital
Outcome results
None listed