Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma

Korábbi kezelés

• Prior treatment with Surufatinib;
• Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment.
• Symptoms that affect oral medication and can not be controlled through proper treatment. (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)
• Accepted surgical treatment, incision biopsy or significant traumatic injury within 28 days before grouping.

Más betegség

• With pleural effusion or ascites, cause respiratory syndrome. (> CTC AE grade 2 dyspnea [grade 2 dyspnea refers to shortness of breath during a small amount of activity; affecting instrumental activities of daily life])
• had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;

Laborértékek

• With severe and failed to controlled diseases. (including:1)Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug treatment).2)Arrhythmias with grade II and above myocardial ischemia or myocardial infarction, poor control (including corrected QT interval(QTc) men ≥ 450 ms, women ≥ 470 ms) and ≥ 2 congestive heart failure (New York Heart Association ( NYHA) rating).3)Poor control of diabetes (fasting blood glucose > 10mmol / L).4)Active or uncontrolled serious infection (≥ Common Terminology Criteria for Adverse Event(CTC AE) grade 2 infection);5)Patients with active hepatitis B or hepatitis C (hepatitis B: HBsAg-positive and hepatitis B virus(HBV) DNA ≥ 500 IU/mL; hepatitis C: hepatitis C virus(HCV) RNA-positive and abnormal liver function), or active infection requiring antimicrobial treatment (eg Treated with antibacterial drugs, antiviral drugs, antifungal drugs);6)renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;7)Patients with seizures and need treatment.)

Egyéb

• had central nervous system metastasis;
• Participated in other anti-tumor clinical trials within 4 weeks.
• were pregnant or breastfeeding.

• Fully understand the study and voluntarily sign the informed consent form;
• Male or female, age14-70 years，the body surface area of patients under 18 years old is ≥1.5m2;
• Histologically or cytologically confirmed advanced osteosarcoma and soft tissue sarcoma (unresectable or metastatic)；
• The patient had previously failed standard chemotherapy,Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 (amputation patients 0-2).
• Life expectancy > 12 weeks.
• Have measurable disease based on RECIST 1.1.