soft tissue sarcoma
Conditions
Interventions
experimental group:Chidamide combined with toripalimab and anlotinib
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.18-85 years old, gender is not limited; 2.ECOG score: 0-1 point; 3.Expected survival period is =3 months: 4.Advanced or unresectable soft tissue sarcoma confirmed by histology or cytology; 5.The front-line chemotherapy with adriamycin as the main drug failed; 6.At least one measurable lesion as the target lesion (according to RECIST v1.1 criteria); 7.The main organs function well 8.Women of childbearing age must undergo a blood pregnancy test within 14 days before enrollment and have a negative result, and are willing to use appropriate contraception methods during the trial and for 6 months after the end of treatment. For men, surgical sterilization should be performed, or they should agree to use appropriate contraception methods during the study and for 3 months after the end of treatment; 9.Volunteer to participate in this study and sign the informed consent form; 10.Good compliance and agreement to cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Patients who have previously used chidamide or other histone deacetylase inhibitors; 2.Patients known to be allergic to the components of the study drug; 3.Patients with other malignant tumors other than the tumors treated in this study, except for: malignant tumors that have been cured and have not relapsed within 3 years before enrollment in the study, completely resected basal cell and squamous cell skin cancers, and completely resected any type of in situ cancer 4.Active central nervous system metastasis (regardless of whether treatment has been received), including symptomatic brain metastasis or meningeal metastasis or spinal cord compression; except for asymptomatic brain metastasis (no progression within at least 4 weeks after radiotherapy and/or no neurological symptoms or signs after surgical resection, without the need for dexamethasone or mannitol treatment); 5.uncontrollable recurrent chest effusion, pericardial effusion, or ascites; 6.The toxicity of previous treatment is still greater than grade 1 (CTCAE V4.03 standard), excluding alopecia and neurotoxicity; 7.Those with a history of mental disorders; 8.Those who have a history of drug abuse or drug abuse after inquiry; 9.Patients with a history of idiopathic pulmonary fibrosis or idiopathic pneumonia, or patients who have undergone extensive lung radiation therapy; 10.Complications requiring treatment with immunosuppressive drugs, or requiring systemic or local use of corticosteroids at immunosuppressive doses (prednisone >10mg/day or equivalent doses of similar drugs); 11.Have a history of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc., except: type I diabetes, hypothyroidism that can be controlled only through hormone replacement therapy, skin diseases that do not need systemic treatment (such as vitiligo, psoriasis), controlled celiac disease Or diseases that are expected to not recur without external stimuli; 12.Previously or currently suffering from active tuberculosis infection; 13.Active infections requiring systemic treatment; 14.Uncontrolled hypertension (systolic blood pressure =140mmHg and/or diastolic blood pressure =90mmHg) or pulmonary hypertension or unstable angina; myocardial infarction or bypass or stent surgery within 6 months before administration; chronic heart failure history meeting the New York Heart Association (NYHA) classification of 3-4; clinically significant valve disease; serious arrhythmia requiring treatment (excluding atrial fibrillation, paroxysmal supraventricular tachycardia), including QTc interval of male =450ms, female =470ms; cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months before administration; 15.Complicated with serious medical diseases, including but not limited to: uncontrolled diabetes, active gastrointestinal ulcer, active bleeding, etc; 16.Positive for Anti-HIV, TP-Ab, HCV-Ab; positive for HBV-Ag and HBV DNA copy number > the upper limit of normal detection unit; 17.Expected major surgery within 28 days before administration or during treatment; 18.Live vaccines or attenuated vaccines are expected to be administered within 4 weeks before administration, during treatment, or within 5 months of the last dose; 19.Participated in another clinical trial and received experimental drug treatment within 30 days before administration; 20.Patients who lack communication, unde
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;OS;CBR; | — |
Countries
China
Contacts
Public ContactYan Wangjun
Fudan University Shanghai Cancer Center
Outcome results
None listed