NCT04260113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

February 5, 2020

Last Update Submit

January 2, 2021

Conditions

EfficacyToxicity, Drug

Keywords

chondrosarcomaapatinibinoperabletoxicityprognosis

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    from initial treatment to date of recorded progression or death or last follow-up

    6 months

Secondary Outcomes (3)

  • overall survival

    5 years

  • objective response rate

    6 months

  • clinical benefit rate

    6 months

Study Arms (1)

Apatinib Arm

EXPERIMENTAL
Drug: Apatinib Mesylate

Interventions

Apatinib MesylateDRUG

Apatinib orally 500mg once daily half an hour after meal

Apatinib Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \) histologically confirmed high-grade sarcoma;
  • \) initial treatment in the orthopedic oncology departments of the two affiliated hospitals of Peking University;
  • \) unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
  • \) measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) ;
  • \) Eastern Cooperative Oncology Group performance status 0 or 1;
  • \) acceptable hematologic, hepatic, and renal function.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Musculoskeletal Tumor Center of Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Peking Univresity Shougang Hospital

Beijing, Beijing Municipality, 100144, China

Location

Related 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.

    PMID: 29625604BACKGROUND

  • 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.

    PMID: 30559126BACKGROUND

  • 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.

    PMID: 32547189RESULT

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsChondrosarcoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

October 1, 2019

Primary Completion

January 1, 2020

Study Completion

April 1, 2020

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)