Apatinib for Inoperable Advanced Chondrosarcoma

NCT ID: NCT04260113

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Efficacy Toxicity, Drug

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apatinib Arm

Group Type EXPERIMENTAL

Apatinib Mesylate

Intervention Type DRUG

Apatinib orally 500mg once daily half an hour after meal

Interventions

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Apatinib Mesylate

Apatinib orally 500mg once daily half an hour after meal

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Musculoskeletal Tumor Center of Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Peking Univresity Shougang Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 29625604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30559126 (View on PubMed)

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.

Reference Type RESULT
PMID: 32547189 (View on PubMed)

Other Identifiers

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CSSG-06

Identifier Type: -

Identifier Source: org_study_id

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