soft-tissue sarcoma
Conditions
Interventions
experimental group:chidamide combined with Envafolimab
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) 18-75 years old, both sexes; 2)ECOG score: 0-1; 3) Expected survival time =3 months: 4) histologically or cytologically confirmed advanced or unresectable soft tissue sarcoma; 5) The number of immunotherapy regimens (excluding PD-L1) failed in the late stage and immunotherapy regimen =1; 6) At least one measurable target lesion (according to RECIST v1.1 criteria); 7) The main organ function is good and meets the criteria: 10) Women of childbearing age must have had a negative blood pregnancy test within 14 days prior to enrollment and be willing to use an appropriate method of contraception during the trial and for 6 months after the end of treatment. For men, surgical sterilization or consent to use an appropriate method of contraception during the study and for 3 months after the end of treatment; 11) voluntarily participate in the study and sign informed consent; 12)The patient had good compliance and agreed to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1) patients with previous exposure to emvolumab, chidamide, or other histone deacetylase inhibitors; 2) patients with known allergy to study drug components; 3) patients with malignant disease other than the tumor treated in the study, except for: cured malignant tumor with no recurrence within 3 years before study entry, completely resected basal and squamous cell skin cancer, and completely resected carcinoma of any type in situ 4) active central nervous system metastases (whether treated or not), including symptomatic brain or meningeal metastases or spinal cord compression; Exclusions were: asymptomatic brain metastases (no progression within at least 4 weeks after radiotherapy and/or no neurological symptoms or signs after surgical resection requiring treatment with dexamethasone or mannitol); 5) uncontrollable pleural effusion, pericardial effusion or ascites requiring recurrent flow; 6) toxicity of previous treatment still > grade 1 (CTCAE V4.03), excluding alopecia and neurotoxicity; 7) patients with a history of mental disorders; 8) having a history of drug use or drug abuse; 9) patients with a history of idiopathic pulmonary fibrosis or idiopathic pneumonia, or those with a history of massive lung irradiation; 10) comorbidities requiring treatment with immunosuppressive drugs or systemic or topical corticosteroids at doses that are immunosuppressive (prednisone >10mg/ day or equivalent); 11) 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 mellitus, hypothyroidism that can be managed with hormone replacement therapy alone, skin conditions (e.g., vitiligo, psoriasis) that do not require systemic treatment, celiac disease that is under control, or conditions that are not expected to return in the absence of external stimuli; 12) have had a history or current active TB infection; 13) active infection requiring systemic therapy; 14) uncontrolled hypertension (systolic blood pressure =140mmHg and/or diastolic blood pressure =90mmHg) or pulmonary hypertension or unstable angina; Patients had myocardial infarction or underwent bypass or stent surgery within 6 months before drug administration; A history of chronic heart failure meeting the New York Heart Association (NYHA) criteria for class 3-4; Clinically significant valvular disease; Severe arrhythmia requiring treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia), including QTc interval =450ms in men and =470ms in women; Cerebrovascular accident (CVA) or transient ischemic attack (TI, etc.) within 6 months before drug administration; 15) complicated with serious medical diseases, including but not limited to: uncontrolled diabetes, active gastrointestinal ulcer, active bleeding, etc.; 16)Anti-HIV, TP-Ab, HCV-Ab positive; Hbv-ag positive and HBV DNA copies >1000; 17) anticipated major surgery within 28 days before or during treatment; 18) expected administration of live or attenuated vaccine 4 weeks before dose, during treatment, or within 5 months of the last dose; 19) participated in another clinical trial and received a trial drug within 30 days before dose administration; 20) insufficient communication, understanding and cooperation of patients, or poor compliance of patients, which can not guarantee the implementation of the protocol; At the investigator's discretion, the trial was not a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;safety; | — |
Countries
China
Contacts
Public ContactXiaofeng Sun
Jiangsu Cancer Hospital
Outcome results
None listed