An interventional study of Methylsulfonic apatinib in Efficacy and Toxicity, sponsored by Peking University People's Hospital. Completed at 2 sites in China. Per ClinicalTrials.gov, last updated 2018-04-10.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of three Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated sarcoma.
The investigators retrospectively analysed files of patients with advanced sarcoma not amenable to curative treatment, who were receiving an apatinib-containing regimen between June 1, 2015 and December 1, 2016. Fifty-six patients were included: 22 osteosarcoma, 10 Ewing's sarcoma, 3 chondrosarcoma and 21 soft tissue sarcoma.
488 studies on the registry are indexed under Osteosarcoma; 124 are open to participants now.
This study's enrollment of 56 is above the median of 40 across 354 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
all patients had been given apatinib alone
Drug: Methylsulfonic apatinib
Some of patients had been given apatinib alone while some of them had been given apatinib+everolimus
Drug: Methylsulfonic apatinib
Some of the patients had been given apatinib alone while some of the patients had been given apatinib together with GT chemotherapy, which was gemcitabine 1000 mg/m2 d1,8 and docetaxel 75 mg/m2 d8 once every 21 day.
Drug: Methylsulfonic apatinib
Patients were given apatinib alone
Drug: Methylsulfonic apatinib
Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.
objective response rate
CR+PR accroding to RECIST 1.1
Time frame: 3 month
progression-free survival, PFS
PFS was defined as time from the start of using apatinib until disease progression or death, whichever occurred first.
Time frame: 4 months and 6 months
duration of response, DOR
The time from appearance of response or stable disease to progression or death was thus considered the DOR
Time frame: 4 months
Overall Survival,OS
OS was defined as time from the start of using apatinib until death.
Time frame: 12 months
toxicity
accroding to the Common Terminology Criteria for Adverse Events 4.0
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2015 to primary completion in Dec 2016, 18 months.
Of 22 interventional studies with no phase under Osteosarcoma, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 114. This study's 18 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital →