Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma

Inclusion Criteria:

• Age between 18-70 years, male or female.
• ECOG performance status <=2.
• Life expectancy >= 3 months.
• Histologically or cytologically confirmed soft tissue sarcoma (GIST excluded).
• Patients must have had a prior anthracycline and/or ifosfamide in either the adjuvant or metastatic setting but not more than one regimen.
• At least one measurable pulmonary metastasis tumor lesions according to RECIST 1.1 criteria.
• Laboratory values: Hemoglobin (Hb) >= 90 g/L and no blood transfusion within 14 days, Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, Platelet (Plt)>= 80 x 10^9/L, Total Bilirubin (Tbil)=< 1.5 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN or =< 5 x ULN if liver metastases are present, Serum creatinine (Cr) =< 1.0 x ULN, Endogenous creatinine clearance (Ccr)> 50 mL/min (Cockcroft-Gault).
• Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and be willing to use effective contraception during study and for 8 weeks after last IMP administration.
• Willingness to participate in study and sign informed consent form.

Exclusion Criteria:

• Females who are pregnant or breastfeeding or have Childbearing potential unwilling to use effective contraception.
• Prior therapy with Gemcitabine, Docetaxel and Endostar.
• Subjects participating in other clinical trials within 4 weeks before enrollment.
• Accompanied by rapid progress of organ invasions, e.g.lesion areas are great than one half of liver or lung or have liver dysfunction.
• Uncontrolled central nervous system disorder or psychiatric illness.
• Current, serious, clinically significant cardiac arrhythmias, symptomatic congestive heart failure, myocardial infarction before enrollment.
• Patients with abnormal bone marrow function: ANC < 1.5 x 10^9/L, Plt < 75 x 10^9/L, Hb < 90g/L.
• Patients with renal dysfunction: Cr > 1.5 x ULN.
• Patients with liver dysfunction: Tbil > 1.5 x ULN.
• Uncontrolled brain metastases.
• Unwillingness or inability to comply with the study protocol.