Advanced Soft Tissue Sarcoma
Conditions
Interventions
Experimental group:GT regimen, once every 3 weeks, up to 6 cycles, the administration is as follows: gemcitabine 1000mg/m2, d1, 8, q3w docetaxel 70mg/m2, d8, q3w sintilimab treatment, the administrati
Sintilimab until disease progression, intolerable adverse reactions, death, or 2 years of sintilimab treatment.
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for inclusion in this study: 1. Age 18~75 years old, gender is not limited; 2. Histopathological confirmation of epithelioid sarcoma; 3. No prior chemotherapy treatment, but other first-line therapy (tazemetostat, etc.) is allowed to enroll; 4. Patients with locally advanced inoperable/metastatic disease; 5. Eastern Cooperative Oncology Group (ECOG) physical condition score (PS) 0~1; 6. Projected survival of more than 3 months; 7. Within 7 days (including 7 days) before screening, the data required by laboratory tests: neutrophil count >=1.5×10^9/L, platelet count >=90×10^9/L, hemoglobin >=90g/L (no blood transfusion within 14 days), serum total bilirubin =50ml/min; 8. Have measurable lesions (RECIST 1.1 criteria); 9. Patients who have received prior anti-PD-1/PD-L1 antibody therapy are allowed to enroll; 10. Subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of this study, understand the required procedures of the study, and are willing to participate in this study.
Exclusion criteria
Exclusion criteria: Anyone with one or more of the following will not be eligible for this study: 1. Received any investigational drug or antineoplastic agent within 4 weeks prior to enrollment; 2. History of other tumors within the past five years, except for cured cervical cancer or basal cell carcinoma of the skin; 3. Symptomatic brain or meningeal metastases (unless the patient has been >treated for 6 months, has a negative imaging result within 4 weeks prior to study entry, and is stable with tumor-related clinical symptoms at the time of study entry); 4. Clinically significant active bleeding; 5. Pregnant or lactating women; Those of childbearing potential who do not take adequate contraceptive measures; 6. Alcohol or drug addiction; 7. Patients with active, or history of autoimmune diseases that may recur (such as: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, etc.), or high-risk patients (such as immunosuppressive therapy after organ transplantation). Exceptions are autoimmune hypothyroidism or skin conditions that do not require systemic treatment with hormone replacement therapy only. 8. Patients who need to be treated with systemic corticosteroids (dose equivalent to >10mg prednisone/day) or other immunosuppressive drugs within 14 days prior to enrollment or during the study. Use of topical or inhaled corticosteroids, or short-term (=7 days) glucocorticoids for the prevention or treatment of non-autoimmune, infrequent, allergic diseases. 9. Failure of vital organs or other serious diseases, including interstitial pneumonia, clinically relevant coronary artery disease, cardiovascular disease or myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable cardiac arrhythmia within 6 months prior to enrollment; 10. Have a history of infection with human immunodeficiency virus, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation, or stem cell transplantation; 11. Patients with chronic hepatitis B active or active hepatitis C. HBV carriers, hepatitis B (DNA titer =103 copies/ml) who have been stable after drug treatment, and cured hepatitis C patients (negative HCV RNA test) can be enrolled. 12. History of severe neurological or psychiatric illness; Severe infection; Active disseminated intravascular coagulation or other concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the patient or affect the patient's completion of the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Progression-Free Survival (PFS);Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactZhang Xiaowei
Fudan University Shanghai Cancer Center
Outcome results
None listed