histologically or cytologically confirmed unresectable osteosarcoma or soft tissue sarcoma (except chemotherapy-insensitive sarcomas such as alveolar soft tissue sarcoma and extraskeletal myxoid chondrosarcoma, soft tissue tumors requiring special treatment such as gastrointestinal stromal tumor and desmoid fibromatosis)
Conditions
Interventions
Experimental Group:liposomal irinotecan+Cyclophosphamide
Sponsors
Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age: 14-70 years old; 2.histologically or cytologically confirmed unresectable osteosarcoma or soft tissue sarcoma (except chemotherapy-insensitive sarcomas such as alveolar soft tissue sarcoma and extraskeletal myxoid chondrosarcoma, soft tissue tumors requiring special treatment such as gastrointestinal stromal tumor and desmoid fibromatosis). 3.Failure or intolerance to first-line standard treatment.(defined as disease progression during treatment or within 6 months after the last treatment); 4.At least one measurable target lesion with no subsequent planned local treatment (according to RECIST v1.1); 5.ECOG performance status of 0 ~ 2; 6.The expected survival time >=3 months; 7.Subject has adequate biological parameters as demonstrated by the following: absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin (Hgb) >=90 g/L; 8.Adequate hepatic function as evidenced by total bilirubin = 3 g/dL; 9.Adequate renal function as evidenced by serum creatinine (Cr)=1.5 x ULN or creatinine clearance >=60 mL/min; 10.Left ventricular ejection fraction (LVEF) >=50%; 11.Subjects agree to use contraception and are not pregnant or breast feeding women; 12.Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.
Exclusion criteria
Exclusion criteria: 1.Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma; 2.previous received irinotecan/irinotecan liposome based therapy in the first line; 3.Massive pleural effusion or ascites requiring intervention; 4.Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment; 5.Active HIV infection; 6.Combined with uncontrollable systemic diseases; 7.Presence of severe gastrointestinal disease; 8.Allergy to or intolerance to therapeutic drugs or their excipients; 9.Presence of central nervous system metastasis; 10.Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1; 11.Received other anti-tumor therapy within 21 days prior to the first dose of study treatment; 12.Patients who are not suitable to participate in this trial for any reason judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Duration of Response;Progress-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZan Shen
Shanghai Sixth People’s Hospital
Outcome results
None listed