Soft Tissue Sarcoma
Conditions
Interventions
Epirubicin Plus Anlotinib group:Epirubicin Plus Anlotinib
Epirubicin Plus Ifosfamide group:Epirubicin Plus Ifosfamide
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Unresectable locally advanced or metastatic soft tissue sarcoma; 2. Age >=18 and =1500/µL, platelets >=80,000/µL, and hemoglobin >=9.0 g/dL; 8. International normalized ratio (INR) <=1.5 × ULN; 9. Serum creatinine <=1.5 × ULN; 10. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 × ULN (or <=5 × ULN in patients with liver metastases), and total bilirubin <=1.5 × ULN; 11. Left ventricular ejection fraction (LVEF) =55% as assessed by Doppler echocardiography; 12. For women of childbearing potential without surgical sterilization, a negative serum or urine hCG test within 7 days before enrollment is required, and they must agree to use adequate contraception during the study and for 3 months after the final dose. Male patients must agree to use adequate contraception during the study and for 3 months after the final dose or have undergone surgical sterilization; 13. Any toxicities related to prior anti-tumor therapy must have recovered to <= Grade 1 (CTCAE v5.0), except alopecia of any grade, which is permitted; 14. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of another concurrent malignant tumor; 2. Symptomatic brain metastases; 3. Active infections, such as HIV infection, hepatitis B virus DNA >=1×10^3 copies/mL, hepatitis C virus RNA above the upper limit of normal, or active tuberculosis; 4. Pregnant or lactating women; 5. History of major surgery or significant trauma within 28 days prior to treatment initiation; 6. Severe cardiovascular or cerebrovascular diseases, including myocardial ischemia or infarction of grade II or above, uncontrolled arrhythmias (including QTc >=450 ms in men or >=470 ms in women), heart failure classified as NYHA class III–IV, or LVEF =3 within 28 days prior to treatment; or presence of unhealed wounds, fractures, active gastric or duodenal ulcers, ulcerative colitis, gastrointestinal diseases with active bleeding, untreated tumors with active bleeding, or other conditions considered by the investigator to pose a risk of gastrointestinal bleeding or perforation; 12. Any other condition deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median Overall Survival;Objective Response Rate;Disease Control Rate;Safety; | — |
Countries
China
Contacts
Public ContactYu Jiang
West China Hospital, Sichuan University
Outcome results
None listed