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Apatinib for Inoperable Advanced Chondrosarcoma (AIAC)

P

Peking University

Status

Completed

Conditions

Toxicity, Drug
Efficacy

Treatments

Drug: Apatinib Mesylate

Study type

Interventional

Funder types

Other

Identifiers

NCT04260113
CSSG-06

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Apatinib Arm
Experimental group
Treatment:
Drug: Apatinib Mesylate

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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