liposarcoma
Conditions
Interventions
group1:Sindilizumab, 200mg administered by IV infusion on day 1 of each cycle, 1 cycle every 3 weeks (Q3W)
Pipecil 200mg D1-D14, 1 cycle every 3 weeks (Q3W). Total of 4 cycles
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. sign written informed consent prior to performing any trial-related processes; 2. males or females aged =18 years and =80 years; 3. subjects with histologically or cytologically confirmed locally advanced liposarcoma that is not amenable to surgical treatment and radical simultaneous radiotherapy and who have not received prior systemic therapy; 4. at least one imaging measurable lesion according to the Criteria for Evaluation of Efficacy in Solid Tumors (RECIST version 1.1). A lesion located within the irradiated field of prior radiotherapy may be considered measurable if progression is confirmed; 5. not have received any prior systemic antitumor therapy for advanced/unresectable disease. Subjects who have received prior adjuvant/neoadjuvant chemotherapy or radical radiotherapy for progressive disease are permitted to enroll in this study if disease progression or recurrence is separated by at least 6 months from the end of the last chemotherapeutic agent treatment; 6. allow enrollment of subjects with brain metastases who are asymptomatic or whose symptoms have stabilized with local therapy, provided the subject meets the following criteria: 1) have a measurable lesion outside the CNS 2) no CNS symptoms or no worsening of symptoms for at least 2 weeks 3) no glucocorticoid therapy is required, or glucocorticoid therapy was discontinued within 7 days prior to the first dose, or the glucocorticoid dosage was stabilized and reduced to less than 10 mg/day of prednisone (or equivalent) within 7 days prior to the first dose 7. patients are permitted to receive palliative radiotherapy provided that the end of radiotherapy is 7 days prior to the first study drug administration and recovery from radiotherapy-related toxicity to less than or equal to grade 1 (CTCAE 5.0) 8. an ECOG score of 0-1; 9. expected survival time > 3 months; 10. adequate organ function, subjects will be required to meet the following laboratory criteria: 1) Absolute neutrophil count (ANC) = 1.5x109/L in the last 14 days without granulocyte colony-stimulating factor; 2) Platelets = 100 x 109/L in the absence of blood transfusion in the last 14 days; 3) Hemoglobin > 9 g/dL without transfusion or erythropoietin use in the last 14 days; 4) total bilirubin = 1.5 times the upper limit of normal (ULN) 5) aspartate aminotransferase (AST), alanine aminotransferase (ALT) at = 2.5 times ULN (subjects with liver metastases are permitted to have ALT or AST = 5 x ULN) 6) Blood creatinine = 1.5 times ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) = 60 ml/min; 7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) = 1.5 times ULN; 8) Normal thyroid function, defined as thyrotropin (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may also be enrolled if total T3 (or FT3) and FT4 are within the normal range (if the combined judgment is that the simple laboratory abnormalities are not clinically significant are also permitted to be enrolled); 9) Cardiac enzyme profiles within the normal range (if the combination of laboratory abnormalities is not clinically significant, enrollment is permitted); 11. for female subjects of childbearing potential, a negative urine or serum pregnancy test should be obtained within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a negative urine pregnancy test result cannot be confirmed, a blood
Exclusion criteria
Exclusion criteria: 1. those whose pathology is soft tissue sarcoma non-liposarcoma; 2. who have received radiation therapy prior to the first study drug administration under one of the following conditions: 1) =30% of the bone marrow has received radiation therapy within 14 days prior to treatment 2)Radiotherapy to the target lesion at a dose >30 Gy within 6 weeks prior to treatment (enrolled subjects must have recovered to grade 1 or less from prior radiotherapy toxicity, not require glucocorticoid therapy and have no history of radiation enteritis) 3) End of palliative radiotherapy within 7 days prior to first study drug administration; 3. diagnosis of malignant disease other than LPS within 5 years prior to the first dose of study drug (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection) 4. currently being treated in an interventional clinical study or have been treated with another investigational drug or with an investigational device within 4 weeks prior to the first dose; 5. prior therapy with: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or agents targeting another stimulatory or synergistic inhibitor of T-cell receptors (e.g., CTLA-4, OX-40, CD137) or treatment with selective inhibitors of CDK 4/6 6. Active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating medications, glucocorticoids, or immunosuppressive agents) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 7. is receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: Physiologic doses of glucocorticoids (=10 mg/day of prednisone or equivalent) are permitted; 8. presence of clinically uncontrollable pleural effusion/abdominal effusion (subjects who do not require drainage of the effusion or who do not have a significant increase in effusion for 3 days after cessation of drainage may be enrolled); 9. known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. known hypersensitivity to the active ingredients or excipients of the study drugs sindilizumab, piperacil, etc.; and 11. have not fully recovered from any intervention-induced toxicity and/or complications (i.e., = Grade 1 or at baseline, excluding malaise or alopecia) prior to initiation of treatment; 12. known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 13. Untreated active hepatitis B (defined as HBsAg positivity accompanied by a detectable HBV-DNA copy number greater than the upper limit of normal in the Laboratory Department of the host research center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: 1) HBV viral load <1000 copies/ml (200 IU/ml) prior to the first dose of study drug, and subjects should receive anti-HBV therapy to avoid viral reactivation for the entire duration of the study drug regimen. 2) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is needed 14. Subjects with act
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Objective mitigation rate;Disease control rate;Duration of relief; | — |
Countries
China
Contacts
Public ContactDechang Diao
Guangdong Provincial Hospital of Traditional Chinese Medicine/ Guangzhou University of Chinese Medicine
Outcome results
None listed