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Completed

NCT Number: NCT04260113

Apatinib for Inoperable Advanced Chondrosarcoma

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Musculoskeletal Tumor Center of Peking University People's Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apatinib Mesylate

Drug

Apatinib orally 500mg once daily half an hour after meal

Primary outcomes

  1. progression-free survival

    Time frame: 6 months

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

Secondary outcomes

  1. overall survival

    Time frame: 5 years

    from initial treatment to death or last follow-up

  2. objective response rate

    Time frame: 6 months

    CR+PR according to RECIST 1.1

  3. clinical benefit rate

    Time frame: 6 months

    CR+PR+SD according to RECIST 1.1

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Acronym: AIAC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2020
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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