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NCT Number: NCT06202599

Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance

This multicenter retrospective study assessed the efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after several lines of TKIs' resistance.

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Key information

Conditions

Bone Sarcoma Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Refractory Tumor Sarcoma Sarcoma, Ewing Soft Tissue Sarcoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

The short-lived duration of disease control and secondary drug resistance have posed a threat to the effect of TKIs. Fruquintinib is a novel TKI with a high selectivity of VEGFR-1,2,3 without metabolism by liver enzymes and was approved for application in mCRC. Serious drug resistance and the unique characteristics of fruquintinib have prompted us to verify whether this drug can reverse TKIs' resistance at a higher dose.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed bone or soft tissue sarcomas;
  • Progressed after several lines of therapy;
  • Previously treated with other TKIs before fruquintinib;
  • Received fruquintinib-based treatment;
  • Measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST) version1.1;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤3

Exclusion criteria

  • Failure to complete regular follow-up after administration.
  • Discontinued the fruquintinib-based treatment due to neither progression nor unacceptable toxicity.

Treatment and study plan

FRUQUINTINIB

Drug

For patients with pulmonary metastasis only, we mostly gave them fruquintinib with 7 mg in adults and 3-5 mg in children (<10 years) orally per day (5 days on and 2 days off). If patients were extrapulmonary metastasis, we usually used combinations with metronomic chemotherapy (2/3 or 3/5 or even 1/2 of the usual dose) or immunotherapy.

Primary outcomes

  1. PFS

    Time frame: 4months

    The time from the first administration of fruquintinib to the date of first documentation of disease progression or death, whichever occurred first.

Secondary outcomes

  1. OS

    Time frame: 1year

    OS was calculated from the use of fruquintinib until death from any cause

  2. ORR

    Time frame: 1year

    ORR was defined as the proportion of patients with the best overall response of complete or partial response(CR+PR) according to the Response Evaluation Criteria for Solid Tumors(RECIST) version 1.1.

  3. DCR

    Time frame: 1year

    DCR was defined as the proportion of patients with the best overall response of complete or partial response or stable disease(CR+PR+SD) according to RECIST 1.1.

  4. AEs

    Time frame: 1year

    AEs were graded and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE ) version 5.0.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance:A Multicenter Retrospective Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2024
Registry last updated
Jan 17, 2024

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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