None listed
Conditions
Interventions
Drug : Arm1- On Day 1 of each 21-day cycle, bevacizumab (Onbevzi) 15 mg/kg will be administered intravenously over 30 minutes, followed by gemcitabine 1000mg/m2 administered intravenously over 30 minu
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed advanced leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), liposarcoma, or angiosarcoma with chemotherapy (= 2 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 -Serum Creatinine: = 50 mL/min -Total Bilirubin: = 1.5 × UNL (upper normal limit) -AST(SGOT): = 3.0 × UNL or = 5.0 × UNL (in patients with liver metastasis) -ALT(SGPT): = 3.0 × UNL or = 5.0 × UNL (in patients with liver metastasis) 6)Female patient of childbearing potential has a negative serum or urine pregnancy test for ß-hCG (If the urine test is positive or inconclusive, a serum pregnancy test may be required.) 7)Able to provide written informed consent and comply with the protocol requirements
Exclusion criteria
Exclusion criteria: 1)Patient who has had chemotherapy, radiotherapy, or biological therapy within 14 days prior to entering the study 2)More than 3 prior cytotoxic agents 3)previously received treatment with bevacizumab, gemcitabine, or docetaxel 4)Unresolved toxicities from prior anticancer therapy = Grade 2 according to NCI CTCAE, excluding alopecia, vitiligo, and laboratory abnormalities defined in the inclusion criteria 5)Major surgery within 28 days prior to randomization. 6)Active or prior documented autoimmune or inflammatory disorders. (e.g., inflammatory bowel disease [ulcerative colitis or Crohn’s disease], diverticulitis [excluding diverticulosis], systemic lupus erythematosus, sarcoidosis, Wegener’s syndrome [granulomatosis with polyangiitis], Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) 7)Unstable cardiovascular disease (coronary angioplasty or stent placement, myocardial infarction, unstable angina, coronary artery bypass grafting, peripheral arterial disease (Grade III) or congestive heart failure (Grade IV) according to the New York Heart Association classification, thromboembolism (patients on stable anticoagulation for =6 weeks are eligible), hemoptysis, intracranial hemorrhage, or clinically significant gastrointestinal bleeding) 8)Has an active infection requiring parenteral treatment 9)History of another primary malignancy. However, enrollment is permitted in the following cases: -Basal cell or squamous cell carcinoma of the skin after curative resection -Cervical carcinoma in situ after at least 1 year following successful treatment -Patients who have been disease-free for at least 3 years after completion of treatment 10)Uncontrolled or active CNS metastasis and/or carcinomatous meningitis -Participants with previously treated brain metastases are eligible if radiologically stable. 11)The patient is pregnant or breastfeeding (or intending to breastfeed within 6 months after the last dose), or plans to conceive or father a child during the study period 12)Pre-existing interstitial lung disease (ILD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) based on RECIST version 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) Safety profile ;Overall survival (OS);Safety profile | — |
Countries
Korea, Republic of
Contacts
Public Contactkum-Hee Yun
Yonsei University Health System, Severance Hospital
Outcome results
None listed