Clinical trial NCT04260113: Apatinib for Inoperable Advanced Chondrosarcoma
Official title: The Effectivity and Toxicity of Apatinib for Unresectable Advanced Chondrosarcoma: a Multicentric Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy
Toxicity, Drug
Keywords: chondrosarcoma
apatinib
inoperable
toxicity
prognosis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: progression-free survival
timeFrame: 6 months
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: objective response rate
timeFrame: 6 months
measure: clinical benefit rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Musculoskeletal Tumor Center of Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Univresity Shougang Hospital
state: Beijing
Study officials:
References:
citation: Xie L, Guo W, Wang Y, Yan T, Ji T, Xu J. Apatinib for advanced sarcoma: results from multiple institutions' off-label use in China. BMC Cancer. 2018 Apr 6;18(1):396. doi: 10.1186/s12885-018-4303-z.
citation: Xie L, Xu J, Sun X, Tang X, Yan T, Yang R, Guo W. Apatinib for Advanced Osteosarcoma after Failure of Standard Multimodal Therapy: An Open Label Phase II Clinical Trial. Oncologist. 2019 Jul;24(7):e542-e550. doi: 10.1634/theoncologist.2018-0542. Epub 2018 Dec 17.
citation: Xie L, Xu J, Sun X, Liu K, Li X, He F, Liu X, Gu J, Lv Z, Yang R, Tang X, Yan T, Li D, Yang Y, Dong S, Sun K, Shen D, Guo W. Apatinib for Treatment of Inoperable Metastatic or Locally Advanced Chondrosarcoma: What We Can Learn About the Biological Behavior of Chondrosarcoma from a Two-Center Study. Cancer Manag Res. 2020 May 15;12:3513-3525. doi: 10.2147/CMAR.S253201. eCollection 2020.