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

NCT ID: NCT06202599

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-25

Study Completion Date

2023-11-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bone Sarcoma Soft Tissue Sarcoma Refractory Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Study group

Fruquintinib treatment group

Fruquintinib

Intervention Type 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.

Interventions

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Fruquintinib

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xie Lu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lu Xie, M.D.

Role: PRINCIPAL_INVESTIGATOR

Musculoskeletal Tumor Center of Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PKUPH-sarcoma 17

Identifier Type: -

Identifier Source: org_study_id

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