Soft Tissue Sarcoma
Conditions
Interventions
Treatment Group:Liposomal irinotecan (II) 40 mg/m2 or 60 mg/m2, administered intravenously on Day 1 every 3 weeks (Q3W), in combination with apatinib 250 mg orally once daily (QD)
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, male or female. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1. 3. Expected survival time >= 3 months. 4. Patients with locally advanced unresectable or metastatic soft tissue sarcoma confirmed by pathological diagnosis. 5. Patients with soft tissue sarcoma who have failed standard therapy or for whom no standard treatment is available. 6. At least one measurable lesion by imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, with the longest diameter >= 10 mm as measured by spiral CT. 7.All acute toxicities related to prior anti-tumor treatments must have resolved to Grade 0–1 (according to NCI CTCAE version 5.0) or to the levels specified in the inclusion/exclusion criteria before enrollment (except for alopecia or other toxicities deemed by the investigator not to pose a safety risk to the subject). Subjects who have undergone major surgery must have fully recovered from surgical complications prior to initiation of study treatment. 8. Adequate major organ function, defined as meeting the following criteria: (1) Hematologic function (no blood transfusion or blood products within 14 days, and no use of G-CSF or other hematopoietic growth factors): a. Hemoglobin (Hb) >= 80 g/L; b. Absolute neutrophil count (ANC) >= 1.5 × 10?/L; c. Platelet count (PLT) >= 80 × 10?/L. (2) Biochemical function: a. Total bilirubin (TBIL) 45 mL/min. 9. Women of childbearing potential must use reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must agree to use effective contraception during the study and for 60 days after the last dose of the study drug. Male subjects must agree to use effective contraception during the study and for 120 days after the last dose of the study drug, or have undergone surgical sterilization. 10. Subjects must voluntarily participate in the study, sign a written informed consent form, demonstrate good compliance, and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may be eligible provided they are clinically stable and meet all of the following criteria: no evidence of radiographic progression for at least 4 weeks prior to the first dose of study treatment; resolution of any neurological symptoms to baseline; no new or enlarging brain metastases; and no use of corticosteroids for at least 7 days prior to study treatment. This exception does not apply to carcinomatous meningitis, which is excluded regardless of clinical stability. 2. Patients with pathologically confirmed osteosarcoma or peripheral nerve sheath tumors. 3. Prior treatment with irinotecan or apatinib. 4. Uncontrolled hypertension (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg) despite optimal medical management. 5. Severe cardiovascular disease, including: myocardial ischemia or myocardial infarction of grade II or higher; poorly controlled arrhythmias (including QTc interval >= 450 ms in males or >= 470 ms in females); New York Heart Association (NYHA) class III–IV heart failure; or left ventricular ejection fraction (LVEF) 1.5 × ULN, or prothrombin time [PT] > ULN + 4 seconds, or activated partial thromboplastin time [APTT] > 1.5 × ULN), bleeding tendency, or current thrombolytic or anticoagulant therapy. 7. Note: Prophylactic use of low-dose heparin (6,000–12,000 U/day in adults) or low-dose aspirin (= 100 mg/day) is permitted provided that INR 38.5°C during screening or prior to first dosing. 9. History of severe arterial or venous thromboembolic events within 12 months prior to enrollment, including cerebrovascular accidents (such as transient ischemic attack, intracerebral hemorrhage, or cerebral infarction) and pulmonary embolism. 10. Major surgery, severe traumatic injury, fracture, or ulcer within 4 weeks prior to enrollment. 11. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active pulmonary tuberculosis; active hepatitis B infection (HBV DNA = 500 IU/mL); hepatitis C infection (positive anti-HCV antibody with HCV-RNA above the lower limit of detection); or co-infection with hepatitis B and hepatitis C. 12. Known history of hypersensitivity or potential intolerance to the study drugs or their excipients. 13. Conditions that may significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction; or history of fistula or gastrointestinal perforation of a hollow organ within 6 months prior to enrollment. 14. History of substance abuse (including psychotropic drugs) that cannot be discontinued, or presence of psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;Overall survival;Duration of relief; | — |
Countries
China
Contacts
Public ContactYang Bo
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed