Gemcitabine and Docetaxel With or Without Bevacizumab (Onbevzi) for Soft Tissue Sarcoma

Inclusion Criteria

• •1. Histologically confirmed advanced leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), liposarcoma, or angiosarcoma with 1-2 prior chemotherapy
• •: neoadjuvnat or adjuvant chemotherapy is counted as one regimen
• •2. Age ≥19 years, \<80 years
• •3. ECOG performance status of 0-1
• •4. Has at least 1 measurable lesion (as defined by RECIST v1.1).
• •5. Has adequate organ function defined by the following criteria:
• •* Hb ≥ 9.0 g/dL
• •* Absolute neutrophil count (ANC) ≥ 1500 /µL
• •* Platelet ≥ 75,000/ µL
• •* Total Bilirubin: ≤ 1.5 × UNL (upper normal limit) (≤ 2 × UNL in patients with liver metastasis)
• •* Serum Creatinine: ≥ 50 mL/min
• •* AST(SGOT)/ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)
• •* Alkaline Phosphatase (ALP): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver or bone metastasis)
• •6. Female patient of childbearing potential has a negative serum or urine pregnancy test for β-hCG
• •7. Able to provide written informed consent and comply with the protocol requirements
• •5. Major surgery within 28 days prior to randomization.
• •6. Active or prior documented autoimmune or inflammatory disorders
• •7. Unstable cardiovascular disease
• •8. Has an active infection requiring parenteral treatment
• •9. History of another primary malignancy
• •10. Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
• •11. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
• •12. Pre-existing interstitial lung disease (ILD)