metastatic soft tissue sarcoma
Conditions
Interventions
conventional chemotherapy (IFO+EPI regimen:IFO+EPI regimen
targeted therapy (Pan apatinib scheme):Pan apatinib scheme
Sponsors
General Hospital of Shenyang Military Area Command
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old male and female; 2. According to the guidelines for the diagnosis and treatment of soft tissue sarcomas, clinical diagnosis or pathological tissue / cytology confirmed metastatic soft tissue sarcoma; 3. At least one measurable lesion: non lymphoid lesions with the longest single path more than 10mm, or lymph node lesions with short diameter larger than 15mm; That lesions has been in progress with the longest diameter more than 10mm after previous intervention, radiotherapy or ablation can aiso be used as target measurable lesions; 4. Patients with non operable metastatic soft tissue sarcoma; 5. Patients has not accepted systemic chemotherapy (systemic chemotherapy and / or molecular targeted therapy). If the patient have received adjuvant chemotherapy after local treatment, the end of chemotherapy needs more than 12 months, and patients with disease progression or metastasis can also be included; 6. The operation has been ended more than 3 months, and the final intervention, radiotherapy and ablation treatment has been ended more than 4 weeks; 7. Expected survival time over 12 weeks; 8. No drugs (including modern Chinese medicine preparations with soft tissue sarcoma indications) for soft tissue sarcoma were used within 2 weeks before the first treatment; 9. The ECOG score less than 2 points; 10. HBV DNA<104copies/ml (2000IU/ml). If HBV DNA is more than 104copies/ml, antiviral therapy (recommended entecavir) should be carried out first, until the HBVDNA below 104copies/ml into the study, and antiviral drugs and monitoring of liver function and hepatitis B virus load should be continue; 11. The main organ function was normal, which met the following criteria: 1) Routine blood test: no blood transfusion, no use of G-CSF (14 days before screening), HB=90g/L; ANC=1.5×10^9/L; PLT=75×10^9/L; 2) biochemical examination: (no use of ALB within 14 days): ALB=28g/L; ALT and AST<5.0 ULN; TBIL=1 .25 ULN; Cr=1.5 ULN; Electrolytes were normal or normal after treatment; 3) routine urine examination: The urine protein is less than or equal to 1+. 12. Patients who voluntarily entered the group, can be treated according to the requirements of the program for diagnosis and treatment and visit 1 after signing the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who were treated with radiotherapy, surgery, or other targeted drugs during the trial; 2. Patients who had the history of alimentary tract hemorrhage or definite gastrointestinal bleeding tendency in the past three monthssuch as: local known active ulcerative lesions, fecal occult blood + +; as long as the fecal occult blood +, gastroscopy should be carried out; 3. Patients with hypertension and who were treated with two or less antihypertensive drugs still diffcultly fall to the following range (systolic blood pressure 16s, APTT>43s, INR = 2), with a bleeding tendency or undergoing thrombolysis, anticoagulation or antiplatelet therapy; 7. Taking drugs that may prolong QTc and / or induce tip twist VT (Tdp), or drugs that affect drug metabolism at the same time; 8. Pregnant or lactating women.Men and women of childbearing age who were unwilling or unable to adopt effective contraception measures; 9. Any significant clinical and laboratory abnormalities, the researchers believe, affect safety evaluators, such as uncontrollable active infections (>NCI-CTCAEv4.0 grade 2), uncontrollable diabetes mellitus (>NCI-CTCAEv4.0 grade 2), grade II or more peripheral neuropathy (NCICTCAEv4.0), congestive heart failure at grade II or above (NCICTCAEv4.0), myocardial infarction within 6 months etc.; 10. There were any history with brain, subdural metastasis or severe psychiatric disease; those with suspected central nervous system metastasis had to be ruled out by cranial MRI; 11..Patients with severe gastric fundus / esophageal varices requiring interventional treatment; 12. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 4 weeks before the first medication; 13. Significant glomerular filtration rate (endogenous creatinine clearance rate 1.5×ULN); 14. Active hepatitis C, that is, anti -HCV positive or HCV-RNA positive and abnormal liver function; 15. People with known history of HIV infection; 16. Other experimental drugs or experimental medical devices were received within 4 weeks before the first medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The progression free survival time (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) ;tumor progression time;objective response rate ;disease control rate; | — |
Countries
China
Contacts
Public ContactZheng Zhendong
General Hospital of Shenyang Military Area Command
Outcome results
None listed