Efficacy, Toxicity, Drug
Conditions
Keywords
chondrosarcoma, apatinib, inoperable, toxicity, prognosis
Brief summary
Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced chondrosarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of two Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated chondrosarcoma.
Interventions
DRUGApatinib Mesylate
Apatinib orally 500mg once daily half an hour after meal
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 1\) histologically confirmed high-grade sarcoma; * 2\) initial treatment in the orthopedic oncology departments of the two affiliated hospitals of Peking University; * 3\) tumors not amenable to curative treatment or inclusion in clinical trials; * 4\) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy; * 5\) measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) ; * 6\) Eastern Cooperative Oncology Group performance status 0 or 1; * 7\) acceptable hematologic, hepatic, and renal function.
Exclusion criteria
* had central nervous system metastasis; * had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia; * had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on; * had pleural or peritoneal effusion that needs to be handled by surgical treatment; * combined with other infections or wounds; * pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 6 months | from initial treatment to date of recorded progression or death or last follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | from initial treatment to death or last follow-up |
| objective response rate | 6 months | CR+PR according to RECIST 1.1 |
| clinical benefit rate | 6 months | CR+PR+SD according to RECIST 1.1 |
Countries
China
Outcome results
None listed