Sarcoma
Conditions
Keywords
SHR-1210, Camrelizumab, Apatinib, Sarcoma, Jilong Yang
Brief summary
To observe the effectiveness of SHR-1210 (Camrelizumab) combined with apatinib in the treatment of unresectable sarcoma patients with chemotherapy failure. The main observations were progression-free survival (PFS) and progression-free control rate (PFR), followed by objective response rate (ORR) (CR+PR), disease control rate (DCR) (CR+PR+SD), and overall survival (OS). To observe the safety of SHR-1210 (Camrelizumab) combined with apatinib in the treatment of sarcoma
Interventions
DRUGCamrelizumab,
Camrelizumab+ Apatinib test group: intravenous injection once every three weeks, Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.
DRUGApatinib
Apatinib single drug control group: Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.
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
* Patients voluntarily join the study, sign informed consent, and have good compliance； * Pathologically confirmed patients with unresectable sarcoma (except GIST), clinical stage using the American Cancer Research Joint Committee (AJCC) TNM staging criteria. At least 1 double-path measurable lesion according to CT or MR I; * At least one chemotherapy regimen (containing an anthracycline) was used to treat patients with disease progression or intolerance according to the solid tumor efficacy evaluation criteria (RECIST 1.1); * Clear cell sarcoma, alveolar soft tissue sarcoma can be directly into the group without chemotherapy; * 14\ 75 years old, PS score: 0\ 2; expected survival period is more than 3 months; * 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); * 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; * 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; * 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 | nvestigators 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