EfficacyAIACNCT04260113

Apatinib for Inoperable Advanced Chondrosarcoma

A study testing Apatinib Mesylate in people with Efficacy and Toxicity, Drug, run by Peking University People's Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Efficacy, Toxicity, Drug
What is being tested?: Apatinib Mesylate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesChina
Study dates: 1 Oct 2019to 1 Apr 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Musculoskeletal Tumor Center of Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Peking Univresity Shougang Hospital
Beijing, Beijing Municipality, 100144

Other trials in China

About this study

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

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.

Conditions: Efficacy, Toxicity, Drug
Being tested: Apatinib Mesylate
Keywords: chondrosarcoma, apatinib, inoperable, toxicity, prognosis
Medical subject headings: Drug-Related Side Effects and Adverse Reactions, Chondrosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Apatinib MesylateDrug
Apatinib orally 500mg once daily half an hour after meal

Study groups in NCT04260113
Study group	Role	What they receive
Apatinib Arm	Experimental	Not described Receives: Drug: Apatinib Mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20191 Apr 2020

First posted7 Feb 2020
Study start1 Oct 2019
Primary completion1 Jan 2020
Study completion1 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for EfficacyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04260113
Sponsor's protocol ID: CSSG-06
Acronym: AIAC
Status last verified: Jan 2021
First submitted: 5 Feb 2020
Last updated: 5 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 29625604
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.
PubMed 30559126
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.
PubMed 32547189

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectivity and Toxicity of Apatinib for Unresectable Advanced Chondrosarcoma: a Multicentric Retrospective Study
ClinicalTrials.gov ID: NCT04260113
Acronym / sponsor ID: AIAC / CSSG-06
Conditions: Efficacy, Toxicity, Drug
Keywords: chondrosarcoma, apatinib, inoperable, toxicity, prognosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Peking University People's HospitalUniversity, hospital or other
Study start: 1 Oct 2019 (actual)
Primary completion: 1 Jan 2020 (actual)
Study completion: 1 Apr 2020 (actual)
First posted: 7 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Apatinib Arm	Experimental	Drug: Apatinib Mesylate

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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) ;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Apatinib MesylateApatinib orally 500mg once daily half an hour after meal	Drug	Apatinib Arm

Primary outcome

progression-free survival
Time frame: 6 months
from initial treatment to date of recorded progression or death or last follow-up

3 secondary outcomes

overall survival
Time frame: 5 years
objective response rate
Time frame: 6 months
clinical benefit rate
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Background: PubMed 29625604Xie 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.
Background: PubMed 30559126Xie 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 publication: PubMed 32547189Xie 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Apatinib Mesylate in people with Efficacy and Toxicity, Drug, run by Peking University People's Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04260113, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.