Clinical trial NCT03491371: Apatinib for Advanced Sarcoma: Results From Multiple Institutions' Off-label Use
Official title: The Effectivity and Toxicity of Methylsulfonic Apatinib for Extensively Pre-treated Advanced Sarcoma: a Multicentric Retrospective Study in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy
Toxicity
Keywords: apatinib
tyrosine-kinase inhibitors
osteosarcoma
Ewing sarcoma
chondrosarcoma
soft-tissue sarcoma
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Shougang Hospital
name: Peking University International Hospital
First posted: 2018-04-09
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 1) histologically confirmed high-grade sarcoma;
* 2) initial treatment in the orthopedic oncology departments of the three 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) \[8\];
* 6) Eastern Cooperative Oncology Group performance status 0 or 1 \[9\]; and 7) acceptable hematologic, hepatic, and renal function.

Exclusion Criteria:

* had been previously exposed to other TKIs;
* 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
* were pregnant or breastfeeding.

Primary outcomes:
measure: objective response rate
timeFrame: 3 month
Secondary outcomes:
measure: progression-free survival, PFS
timeFrame: 4 months and 6 months
measure: duration of response, DOR
timeFrame: 4 months
measure: Overall Survival,OS
timeFrame: 12 months
measure: toxicity
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Musculoskeletal Tumor Center of Peking University People's Hospital
city: Beijing
country: China
facility: Peking University Shougang Hospital
Study officials:
References: