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Completed

NCT Number: NCT03491371

Apatinib for Advanced Sarcoma: Results From Multiple Institutions' Off-label Use

Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced sarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of three Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated sarcoma.

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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, China

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About this study

The investigators retrospectively analysed files of patients with advanced sarcoma not amenable to curative treatment, who were receiving an apatinib-containing regimen between June 1, 2015 and December 1, 2016. Fifty-six patients were included: 22 osteosarcoma, 10 Ewing's sarcoma, 3 chondrosarcoma and 21 soft tissue sarcoma.

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 three 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) [8];
  • 6) Eastern Cooperative Oncology Group performance status 0 or 1 [9]; and 7) acceptable hematologic, hepatic, and renal function.

Exclusion criteria

  • had been previously exposed to other TKIs;
  • 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
  • were pregnant or breastfeeding.

Treatment and study plan

Methylsulfonic apatinib

Drug

Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

Primary outcomes

  1. objective response rate

    Time frame: 3 month

    CR+PR accroding to RECIST 1.1

Secondary outcomes

  1. progression-free survival, PFS

    Time frame: 4 months and 6 months

    PFS was defined as time from the start of using apatinib until disease progression or death, whichever occurred first.

  2. duration of response, DOR

    Time frame: 4 months

    The time from appearance of response or stable disease to progression or death was thus considered the DOR

  3. Overall Survival,OS

    Time frame: 12 months

    OS was defined as time from the start of using apatinib until death.

  4. toxicity

    Time frame: 12 months

    accroding to the Common Terminology Criteria for Adverse Events 4.0

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Peking University International Hospital
  • Peking University Shougang Hospital

Registry information

Official study title

The Effectivity and Toxicity of Methylsulfonic Apatinib for Extensively Pre-treated Advanced Sarcoma: a Multicentric Retrospective Study in China

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 9, 2018
Registry last updated
Apr 10, 2018

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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