soft tissue sarcoma
Conditions
Interventions
Cohort 1:vorolanib combined with chemotherapy
Cohort 2:vorolanib combined with epigenetic drugs
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Various histologically confirmed subtypes of soft tissue sarcomas; 2.Cohort 1: Advanced or unresectable soft tissue sarcoma that is relatively sensitive to chemotherapy and has failed first-line or higher standard treatment (refer to the NCCN guidelines and ASCO guidelines for the selection of specific chemotherapy-sensitive tumors); Cohort 2: Advanced or unresectable soft tissue sarcoma that is relatively insensitive to chemotherapy and has failed one or more lines of standard treatment (refer to the NCCN guidelines and ASCO guidelines for the specific selection of tumors that are relatively insensitive to chemotherapy). 3.ECOG PS 0 -1; 4.At least one measurable lesion that meets RECIST 1.1 criteria; 5.Age =16; 6.Expected survival period = 3 months; 7.Within 7 days before treatment, the major organ function meets the following criteria: (1)Blood routine examination standards (without blood transfusion within 14 days): ? hemoglobin (HB) = 90g/L; ? absolute neutrophil count (ANC) = 1.5×109/L; ? platelets (PLT) = 80×109/L; (2)Biochemical examinations must meet the following criteria: ? total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); ? alanine aminotransferase (ALT) and aspartate aminotransferase AST = 2.5 × ULN. If accompanied by liver metastasis, ALT and AST = 5 × ULN; ? serum creatinine (Cr) = 1.5 × ULN or creatinine clearance (CCr) = 60 ml/min; (3)Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = lower limit of normal value (50%); 8.Agree to use contraceptive measures.
Exclusion criteria
Exclusion criteria: 1.Patients who have received anti-angiogenic drugs previously; 2.Having or currently having other malignant tumors within 5 years; 3.Patients with pleural effusion or ascites, causing respiratory syndrome (=CTC AE grade 2 dyspnea [grade 2 dyspnea refers to shortness of breath during minimal activity; affecting instrumental daily activities]), and whose symptoms cannot be controlled by symptomatic treatment; 4.Active central nervous system (CNS) metastases with clinical symptoms (including cerebral edema, steroid requirement, or progressive disease); 5.Participated in other anti-tumor drug clinical trials within four weeks; 6.Patients with any severe and/or uncontrolled medical condition, including: (1)Patients with poorly controlled blood pressure (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); (2)Patients with myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QTC =480ms) and congestive heart failure of grade 2 or above (New York Heart Association (NYHA) classification); (3)Active or uncontrolled serious infection (=CTC AE grade 2 infection); (4)Patients with cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis need antiviral treatment; (5)renal failure requiring hemodialysis or peritoneal dialysis; (6)Poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L); (7)Urinalysis showed urine protein =++, and confirmed that the 24-hour urine protein was >1.0 g; (8)Patients who have seizures and require treatment; 7.According to the investigator's judgment, patients with concomitant diseases that seriously endanger patient safety or affect the patients' completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;12 weeks Progression Free Survival Rate;Disease Control Rate;Overall Survival;Quality of Life; | — |
Countries
China
Contacts
Public ContactYutao Liu
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed