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Apatinib for Inoperable Advanced Chondrosarcoma (AIAC)

Primary Purpose

Efficacy, Toxicity, Drug

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Apatinib Mesylate
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy focused on measuring chondrosarcoma, apatinib, inoperable, toxicity, prognosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Musculoskeletal Tumor Center of Peking University People's Hospital
  • Peking Univresity Shougang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib Arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

overall survival
from initial treatment to death or last follow-up
objective response rate
CR+PR according to RECIST 1.1
clinical benefit rate
CR+PR+SD according to RECIST 1.1

Full Information

First Posted
February 5, 2020
Last Updated
January 2, 2021
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04260113
Brief Title
Apatinib for Inoperable Advanced Chondrosarcoma
Acronym
AIAC
Official Title
The Effectivity and Toxicity of Apatinib for Unresectable Advanced Chondrosarcoma: a Multicentric Retrospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy, Toxicity, Drug
Keywords
chondrosarcoma, apatinib, inoperable, toxicity, prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apatinib Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Apatinib Mesylate
Intervention Description
Apatinib orally 500mg once daily half an hour after meal
Primary Outcome Measure Information:
Title
progression-free survival
Description
from initial treatment to date of recorded progression or death or last follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival
Description
from initial treatment to death or last follow-up
Time Frame
5 years
Title
objective response rate
Description
CR+PR according to RECIST 1.1
Time Frame
6 months
Title
clinical benefit rate
Description
CR+PR+SD according to RECIST 1.1
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Musculoskeletal Tumor Center of Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Peking Univresity Shougang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100144
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29625604
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.
Results Reference
background
PubMed Identifier
30559126
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.
Results Reference
background
PubMed Identifier
32547189
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.
Results Reference
result

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Apatinib for Inoperable Advanced Chondrosarcoma

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