Soft Tissue Sarcoma
Conditions
Interventions
Trial Group:Administration of anthracycline-based chemotherapy in combination with immune checkpoint inhibitors
Control Group:Administration of anthracycline-based chemotherapy alone
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The patient voluntarily participates in this study and signs the informed consent form. 2.Aged 18 to 75 years. 3.ECOG Performance Status (PS) score: 0-1, with an expected survival of more than three months. 4.Patients with locally advanced intermediate to high-grade soft tissue sarcoma confirmed by pathology: non-specific soft tissue sarcoma that is relatively sensitive to chemotherapy, such as synovial sarcoma, myxoid/round cell liposarcoma, uterine leiomyosarcoma, and pleomorphic undifferentiated sarcoma, etc. 5.Histological grade FNCLCC 2/3 (Grade 2/Grade 3). 6.Stage IIb-III (according to the eighth edition of the AJCC staging system), including locally advanced soft tissue sarcoma patients with large tumor volume (greater than 5 cm), involvement of vital organs, close relationship with surrounding important blood vessels and nerves, and those for whom surgical resection is not expected to achieve a safe surgical margin or would result in significant functional impairment or even life-threatening conditions after resection. 7.The function of major organs must meet the following criteria within seven days prior to treatment: (1) Hematological examination criteria (without blood transfusion within 14 days): 1)Hemoglobin (HB) >=90 g/L; 2)Absolute neutrophil count (ANC) >=1.5×10?/L; 3)Platelets (PLT) >=80×10?/L. (2) Biochemical examination criteria: 1)Total bilirubin (TBIL) =60 ml/min. (3) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >=the lower limit of normal (50%). 8.Women of childbearing age must agree to use contraceptive measures (such as intrauterine devices, oral contraceptives, or condoms) during the study and for six months after the study ends; they must have a negative serum or urine pregnancy test within seven days before enrollment and must not be breastfeeding. Men must agree to use contraceptive measures during the study and for six months after the study ends.
Exclusion criteria
Exclusion criteria: 1.The patient has not previously received anti-PD-1/PD-L1 inhibitor therapy. If the patient has received adjuvant therapy and experiences recurrent disease more than six months after the end of such therapy, it is not considered a failure of prior anti-PD-1/PD-L1 inhibitor therapy and is not grounds for exclusion. 2.The patient has had or currently has other malignancies within the past five years, with the exception of cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)]. 3.Patients with severe thyroid dysfunction after optimal medical treatment. 4.Patients with any severe and/or uncontrolled diseases, including: (1)Hypertension that cannot be controlled to normal levels (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) despite antihypertensive therapy within the past three months. (2)Clinically significant cardiovascular or cerebrovascular disease, including but not limited to severe acute myocardial infarction within six months prior to enrollment, unstable or severe angina, coronary artery bypass grafting, congestive heart failure (New York Heart Association (NYHA) class >2), ventricular arrhythmias requiring medical intervention, left ventricular ejection fraction (LVEF) =480 ms), and Grade 2 or higher congestive heart failure (New York Heart Association (NYHA) classification). (3)Active or uncontrolled severe infection (>=CTCAE Grade 2 infection). (4)Objective evidence of a history of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, or severely impaired lung function. (5)Cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral therapy. (6)Renal failure requiring hemodialysis or peritoneal dialysis. 5.Patients with any active autoimmune disease or a history of autoimmune disease requiring treatment, including but not limited to hepatitis, pneumonia, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, vitiligo, except for patients with resolved childhood asthma/atopic disease. Asthma requiring intermittent use of bronchodilators or other medical interventions should also be excluded. 6.History of immunodeficiency, including human immunodeficiency virus (HIV) or other acquired or congenital immunodeficiency diseases or active hepatitis (transaminases not meeting inclusion criteria, hepatitis B virus (HBV) DNA >=104/ml or hepatitis C virus (HCV) RNA >=10³/ml or higher); chronic hepatitis B virus carriers with hepatitis B virus DNA 10 mg/day prednisone or equivalent are prohibited within two weeks before the administration of the study drug. Note: The use of corticosteroids for the prevention of IV contrast allergy is permitted. 8.Poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L). 9.Patients with a history of seizures requiring treatment. 10.Abnormal coagulation function (international normalized ratio of prothrombin time(INR) >1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Disease-Free Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Disease Control Rate,DCR;Overall survival,OS;Pathological Response Grading;R0 resection rate;Safety; | — |
Countries
China
Contacts
Public ContactYutao Liu
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed