soft tissue sarcoma
Conditions
Interventions
Experimental group:Fruquintinib (5mg) once daily, orally, d1-21, Q4w
Until PD, death, or intolerable toxicity. 28 days is a treatment cycle.
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in the study, sign the informed consent, and have good compliance; 2. Age >=18 years old; 3. Histologically or cytologically confirmed unresectable soft tissue sarcomas, including but not limited to leiomyosarcoma, undifferentiated pleomorphic sarcoma, liposarcoma, synovial sarcoma, etc., excluding gastrointestinal stromal tumor, extraosseous myxoid chondrosarcoma, extraosseous osteosarcoma, protuberant dermatofibrosarcoma; 4. Patients with soft tissue sarcoma who have previously received antiangiogenic or chemotherapy treatment failure. Treatment failure was defined as disease progression during treatment or within 6 months after the last treatment; Or the toxic side effects of treatment are intolerable. (Note: Neoadjuvant or adjuvant chemotherapy is allowed for prior anti-angiogenesis or chemotherapy therapy. If disease progression/recurrence occurs during neoadjuvant/adjuvant therapy or within 6 months after the end of treatment, previous anti-angiogenesis or chemotherapy therapy is considered to have failed); 5. Must have at least one measurable lesion (RECIST 1.1) (patients receiving neoadjuvant or adjuvant therapy must have at least one measurable lesion before treatment (RECIST 1.1)); 6.ECOG physical status 0 or 1 points (PS 0-2 points for amputees); 7. Expected survival >=12 weeks; 8. Blood test (without blood transfusion within 14 days) (1) Neutrophil absolute value >=1.5×109/L, platelets >=100×10^9/L, hemoglobin concentration >=9g/dL); (2) Liver function test (aspartate aminotransferase and glutamic aminotransferase =60ml/min); (4) Coagulation, International standardized ratio (INR) <=1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) <=1.5×ULN; (5) Thyroid function, thyroid stimulating hormone (TSH) <= the upper limit of normal (ULN); If abnormal, T3 and T4 levels should be examined. If T3 and T4 levels are normal, they can be selected. 9. Women of childbearing age must take a serum pregnancy test with a negative result within 7 days prior to treatment and be willing to use a medically approved effective contraceptive (e.g., IUD, contraceptive or condom) during the study period and within 3 months after the last dose of the study drug; For male subjects whose partner is a woman of childbearing age, surgical sterilization is required or effective contraception is recommended during the study period and within 3 months after the last study dosing; The young patient's parents/guardians have the ability to understand, consent to, and sign the study informed Consent form (ICF) before initiating any project-related procedures; Subject may express consent with parental/guardian consent (if applicable).
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received Fruquintinib treatment; 2. The patient has current central nervous system (CNS) metastases or previous brain metastases; 3. Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 4. Obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months prior to treatment (bleeding within 3 months > 30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks > 5 mL of fresh blood), etc. Or treatment of venous/venous thrombosis events within the preceding 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin >=300 mg/day or clopidogrel >=75 mg/day) is required; 5. Active heart disease, including myocardial infarction, severe/unstable angina in the 6 months prior to treatment. Left ventricular ejection fraction by echocardiography 450 ms, female > 470 ms); 6. The patient has had other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within the previous 3 years or at the same time; 7. Known allergy to the investigational drug or any of its excipients; 8. Active or uncontrolled severe infection; 9. Known human immunodeficiency virus (HIV) infection; 10. Known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., positive HBV DNA (>1×10^4 copies /mL or >2000 IU/ml); 11. Known hepatitis C virus infection (HCV) and HCV RNA positive (> 1×10^3 copies /mL), or other hepatitis, cirrhosis]; 12. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, in which, in the investigator's judgment, there is reason to suspect that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or that would affect the interpretation of the study results or place the patient at high risk; Urine routine indicated urinary protein >=2+, and 24-hour urinary protein quantification > 1.0g.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate;Safety; | — |
Countries
China
Contacts
Public ContactYan Wangjun
Fudan University Shanghai Cancer Center
Outcome results
None listed