Soft Tissue Sarcoma
Conditions
Keywords
Soft tissue sarcoma, apatinib, Jilong Yang
Brief summary
To observe the efficacy of apatinib combined with AI regimen chemotherapy compared with AI regimen chemotherapy and single-agent apatinib in patients with unresectable soft tissue sarcoma. The main observations were progression-free survival (PFS) and progression-free control rate (PFR), followed by objective response rates (ORR, CR+PR), disease control rate (DCR, CR+PR+SD), and overall survival ( OS). To observe the safety of apatinib combined with AI chemotherapy.
Interventions
DRUGApatinib Mesylate, Pirarubicin, Ifosfamide
Apatinib 500mg, orally, once a day. One cycle every 4 weeks. Pirarubicin 75mg/m2 D1, intravenous infusion for 1-2 hours; every 4 weeks. Ifosfamide 2g/m2/d D1-D5, intravenously for 4-6 hours, 1 cycle every 4 weeks.
DRUGApatinib Mesylate
Apatinib 500mg, orally, once a day. One cycle every 4 weeks.
DRUGPirarubicin, Ifosfamide
Pirarubicin 75mg/m2 D1, intravenous infusion for 1-2 hours; every 4 weeks. Ifosfamide 2g/m2/d D1-D5, intravenously for 4-6 hours, 1 cycle every 4 weeks
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients voluntarily join the study, sign informed consent, and have good compliance; 2. A distantly metastatic or locally advanced and soft tissue sarcoma subject determined by the investigator not suitable for surgical treatment (Confirmed by pathology or cytology, except for gastrointestinal stromal tumors, cartilage-bone tumors, embryonic/acinar rhabdomyosarcoma, Ewing's sarcoma, and distant metastatic soft tissue tumors such as dermatofibrosarcoma And inflammatory myofibroblastic sarcoma, clear cell sarcoma and alveolar soft tissue sarcoma, etc). 3. The clinical staging is based on the TNM staging criteria of the American Joint Committee on Cancer Research (AJCC). At least one double-path measurable lesion according to CT or MR I; 4. Patients who have not previously received chemotherapy for soft-tissue sarcoma; or who have benefited from chemotherapy and who have relapsed or metastasized more than 6 months after discontinuation of the drug. The accumulated amount of anthracycline used in the past \<450mg/m2. 5. 14\ 75 years old, PS score: 0\ 1 (Amputation patient can be relaxed to 2 points); the expected survival time is more than 3 months; 6. All acute toxic reactions caused by previous anti-tumor treatment or surgery are relieved to 0-1 before screening (according to NCI CTCAE version 4.03) or to the level specified by the enrollment/
Exclusion criteria
(alopecia, etc. Except for toxicity that does not pose a safety risk to the subject); 7. There are sufficient organ and bone marrow functions, defined as follows: Blood routine (no blood transfusion within 14 days before treatment, no use of G-CSF, no use of drugs to correct), Neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109/L), Platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L), Hemoglobin (Hb) ≥ 9 g/dL (90 g/L); Blood chemistry, Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Cockroft-Gault formula) ≥ 60 ml / min, Total bilirubin (TBIL) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 × ULN, liver metastases should be ≤ 5 × ULN; Coagulation, International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; Urine routine, Urine protein \<2+; if urine protein ≥ 2+, 24-hour urine protein quantitation shows that the protein must be ≤ 1g; Thyroid function, Thyroid stimulating hormone (TSH) ≤ ULN; if abnormalities should be considered T3 and T4 levels, T3 and T4 levels can be selected; 8. Female subjects of childbearing age must undergo a serum pregnancy test within 7 days prior to treatment and the results are negative, and are willing to use a medically recognized effective contraceptive measure during the study period and within 3 months after the last administration of the study drug (eg: Intrauterine devices, contraceptives or condoms; for male subjects whose partners are women of childbearing age, surgical sterilization is required, or an effective method of contraception is recommended during the study period and within 3 months after the last study administration; 9. With my consent and signed informed consent, I am willing and able to follow planned visits, research treatments, laboratory tests and other testing procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Within 2 years | PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate(DCR） | Within 2 years | Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1） |
| Objective tumor response rate(ORR) | Within 2 years | ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments. |
| Overall survival(OS) | Within 3 years | OS is defined as the length of time from random assignment to death or to last contact. |
Countries
China
Contacts
Primary ContactJilong Yang, M.D., Ph.D
Outcome results
None listed