Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT01812018
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01812018
Study Brief:
Protocol Section:
NCT01812018