AIAC: Apatinib for Inoperable Advanced Chondrosarcoma

Sponsor

Peking University People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04260113

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Efficacy Toxicity, Drug	Drug: Apatinib Mesylate	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Apatinib Arm	Drug: Apatinib Mesylate Apatinib orally 500mg once daily half an hour after meal

Arm

Intervention/Treatment

Experimental: Apatinib Arm

Drug: Apatinib Mesylate

Apatinib orally 500mg once daily half an hour after meal

Outcome Measures

Primary Outcome Measures

progression-free survival [6 months]
from initial treatment to date of recorded progression or death or last follow-up

Secondary Outcome Measures

overall survival [5 years]
from initial treatment to death or last follow-up
objective response rate [6 months]
CR+PR according to RECIST 1.1
clinical benefit rate [6 months]
CR+PR+SD according to RECIST 1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. histologically confirmed high-grade sarcoma;
1. initial treatment in the orthopedic oncology departments of the two affiliated hospitals of Peking University;
1. tumors not amenable to curative treatment or inclusion in clinical trials;
1. unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
1. measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) ;
1. Eastern Cooperative Oncology Group performance status 0 or 1;
1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Musculoskeletal Tumor Center of Peking University People's Hospital	Beijing	Beijing	China	100044
2	Peking Univresity Shougang Hospital	Beijing	Beijing	China	100144