Apatinib for Inoperable Advanced Chondrosarcoma

Efficacy Clinical Trial

— AIAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260113
• Other study ID #: CSSG-06
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: January 2021
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chondrosarcoma
• Drug-Related Side Effects and Adverse Reactions
• Efficacy
• Toxicity, Drug

Intervention

Drug:
• Apatinib Mesylate
Apatinib orally 500mg once daily half an hour after meal

Locations

Country	Name	City	State
China	Musculoskeletal Tumor Center of Peking University People's Hospital	Beijing	Beijing
China	Peking Univresity Shougang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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 Behavio — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	from initial treatment to date of recorded progression or death or last follow-up	6 months
Secondary	overall survival	from initial treatment to death or last follow-up	5 years
Secondary	objective response rate	CR+PR according to RECIST 1.1	6 months
Secondary	clinical benefit rate	CR+PR+SD according to RECIST 1.1	6 months