retroperitoneal dedifferentiated liposarcoma
Conditions
Interventions
Arm A:Neoadjuvant sintilimab monotherapy
Arm B:Neoadjuvant sintilimab combined with epirubicin and/or ifosfamide
Sponsors
Department of Urology, Shanghai Changhai Hospital, the Second Military Medical University, Shanghai, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adult subjects >= 18 years old 2. ECOG score as 0,1,2 3. Must be immunotherapy-na?ve 4. Treatment-na?ve primary or locally recurrent RP DDLPS 5. Patients having received previous standard chemotherapy for another malignancy are eligible after a 28-day wash-out period 6. RP DDLPS evaluate to be surgically resectable and are candidates for subsequent surgery as agreed upon by multidisciplinary agreement 7. Must be suitable to perform surgery medically 8. Recent imaging within 4 weeks of trial enrollment, demonstrating measure disease as defined by RECIST 1.1 9. Must have at least one tumor amenable to serial biopsy in clinic or be willing to perform serial biopsies through image-guided procedures during the neoadjuvant phase of the trial 10. Patients must have organ/marrow function as defined below: a. WBC > 3 K/µL, ANC > 1 K/µL b. hemoglobin > 9 g/dL c. platelets > 1000 K/mm3 d. serum creatinine 50 mL/min e. AST < 1.5 x upper limit of normal, ALT < 1.5 x upper limit of normal, bilirubin < 1.5 x upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. Active, known, or suspected autoimmune disease; 2. Condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study pharmacotherapy; 3. Known history of testing positive for HIV or known acquired immunodeficiency syndrome; 4. Acute or chronic infection indicated by any positive test results for hepatitis B or C virus; 5. Previous intraabdominal surgery within 4 weeks of trial enrollment; 6. Previous chemotherapy for treatment of the sarcoma under consideration for resection or radiation therapy for sarcoma in the same area; 7. Active concurrent second malignancy; 8. Current use of anticoagulants at therapeutic levels; 9. Recurrence based on imaging in 3 weeks after preoperative treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathology response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| the changes of imaging;PFS and OS time;the comparison of efficacy of two groups;biomarkers; | — |
Countries
China
Contacts
Public ContactChen Rui
Department of Urology, Changhai Hospital
Outcome results
None listed