Retroperitoneal Sarcoma
Conditions
Interventions
Drug+ Surgery:Apatinib combined with SHR-1210( Before the surgery)
Sponsors
Beijing Cancer Hospital / Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients have signed informed consent; 2. Aged >= 18 years; 3. Patients who were diagnosed as retroperitoneal sarcoma by imaging diagnostics, and the tumor was evaluated to be completely removed by surgery; and even if the tumor continues to progress, it can be completely removed by surgery; 4. The subjects has not previously received systemic anti-angiogenics therapy or PD-1 monoclonal antibody drug therapy; 5. The subject has measurable lesions in accordance with the international general tumor evaluation standard RECIST 1.1; 6. The blood routine and biochemical indicators of the subjects met the following standards at the time of enrollment: (1) Hemoglobin >= 90 g/L; (2) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; (3) Platelet >= 100 x 10^9/ L; d) Serum albumin >= 30 g/L; (4) ALT and AST <= 2.5 times the upper limit of normal; (5) Serum total bilirubin < 1.5 times the upper limit of normal; (6) Serum creatinine < 1.5 times the upper limit of normal Limit; 7. ECOG score is 0-2 points; 8. Cardiopulmonary function is basically normal and meets the requirements of surgery; 9. Women of childbearing age and their spouses are willing to adopt effective contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating women or women of childbearing age and their spouses refuse to use effective contraceptive methods for contraception; 2. Patients who have a history of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation); 3. Patients who have a long history of systemic steroid therapy (Note: short-term users who stop taking the drug for more than 2 weeks can be include); 4. Patients who have peripheral nervous system disorders or have obvious mental disorders and a history of central nervous system disorders; 5. Patients who have severe infections that require treatment; 6. Patients with dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation, etc.; 7. Patients with severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrollable chronic system diseases such as diabetes, hypertension, etc. 8. Patients with heart diseases with obvious clinical symptoms, such as: congestive heart failure, coronary heart disease with obvious symptoms, arrhythmia/hypertension that is difficult to control with drugs, or myocardial infarction within 6 months, or cardiac insufficiency. 9. Patients who are incapable of legal conduct, and those whose medical or ethical reasons affect the continuation of research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival, DFS;Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative Safety;Overall survival, OS;clinicopathological characteristics; | — |
Countries
China
Contacts
Public ContactHao Chunyi
Peking University Cancer Hospital
Outcome results
None listed