Apatinib for Inoperable Advanced Chondrosarcoma

Study Overview
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Brief Summary
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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.

Official Title
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The Effectivity and Toxicity of Apatinib for Unresectable Advanced Chondrosarcoma: a Multicentric Retrospective Study

Conditions
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Efficacy, Toxicity, Drug

Intervention / Treatment
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* Drug: Apatinib Mesylate


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib Arm<br> | Drug: Apatinib Mesylate<br>* Apatinib orally 500mg once daily half an hour after meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | from initial treatment to date of recorded progression or death or last follow-up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | from initial treatment to death or last follow-up | 5 years | 
| objective response rate | CR+PR according to RECIST 1.1 | 6 months | 
| clinical benefit rate | CR+PR+SD according to RECIST 1.1 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chondrosarcoma, apatinib, inoperable, toxicity, prognosis