Advanced soft tissue sarcoma
Conditions
Interventions
Liposomal doxorubicin plus Chidamide treatment group: Liposomal doxorubicin plus Chidamide
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years old and =65 years old; 2) Patients with locally advanced unresectable or metastatic soft tissue sarcoma confirmed by histopathology (excluding rhabdomyosarcoma, chondrosarcoma, osteosarcoma, Ewing's sarcoma/primary neuroectodermal tumor, inflammatory myofibroblastic sarcoma, protruding skin fibrosarcoma, acinar soft tissue sarcoma, cellular sarcoma, uterine stromal sarcoma, gastrointestinal stromal tumor, malignant mesothelioma, Kaposi's sarcoma); (3) No major surgery has been performed within 28 days; (4) No prior systemic first-line therapy (except adjuvant therapy, which did not use anthracyclines); (5) ECOG score 0-2; Expected survival of at least 3 months; (6) There is at least one measurable objective tumor lesion with a maximum diameter of =1cm examined by spiral CT; (7) No other serious diseases; (8) Female patients are not pregnant or breastfeeding, and all patients agree to take the treatment during the trial period and within 6 months after the end of the trial Contraceptive measures; (9) Routine peripheral blood examination before treatment meets the following conditions: hemoglobin (HB)=80g/L, absolute value of neutrophil (ANC) =1.5×109/L, platelet (PLT)=80×109/L; (10) Liver and kidney function tests before treatment meet the following conditions: bilirubin =1.5 times the upper limit of normal value, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 times the upper limit of normal, if with liver metastasis, ALT and AST=5 times the upper limit of normal; Serum creatinine =1.5 times the upper limit of normal. (11) Preoperative cardiac ultrasonography assessment: left ventricular ejection fraction (LVEF) = the lower limit of normal (50%). (12) Participate in the study voluntarily and sign informed consent before starting the study.
Exclusion criteria
Exclusion criteria: (1) A history of other malignancies (fully treated basal cell carcinoma of the skin, except cervical cancer in situ); (2) Adjuvant therapy for patients who have received anthracyclines, sidarbenamine, or other histone deacetylase inhibitors; Join a group Patients who have received systemic therapy (including chemotherapy, targeted therapy, biotherapy, immunotherapy, etc.) or radiotherapy in the previous 4 weeks; (3) Patients with brain metastases accompanied by symptoms or symptoms controlled for less than 2 months; (4) uncontrolled active infection; (5) Received radiotherapy within 4 weeks before enrollment; (6) Concurrent serious illnesses or conditions that affect the safety of patients during normal enrollment or the study period (such as blood pressure and glucose control) Unsatisfactory, prolonged Q-T interval, myocardial infarction, arrhythmia, liver cirrhosis, renal failure, immune deficiency diseases, etc.); (7) Positive pregnancy test for women of childbearing age; (8) Active mental disorders or other mental disorders that affect the patient's ability to sign informed consent and understand; (9) Those who were not considered suitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose;Dose-limiting toxicity;Recommended dosage for Phase II study; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Objective response rate;Safty;Potential predictive biomarkers; | — |
Countries
China
Contacts
Public ContactDeng Yaotiao
West China Hospital, Sichuan University
Outcome results
None listed