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

NCT06202599 | Completed

• 1 other identifier: PKUPH-sarcoma 17
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Sarcoma; Soft Tissue Sarcoma; Refractory Tumor

Keywords

Fruquintinib; Osteosarcoma; Ewing sarcoma; Soft Tissue Sarcomas; TKIs

Outcome Measures

Primary Outcomes (1)

• PFS

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

  4months

Secondary Outcomes (4)

• OS

  1year

• ORR

  1year

• DCR

  1year

• AEs

  1year

Study Arms (1)

Study group

Fruquintinib treatment group

Drug: Fruquintinib

Interventions

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.

Study group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received fruquintinib-based treatment with refractory bone and soft tissue sarcomas in Peking University People's Hospital and The Second Affiliated Hospital ZheJiang University School of Medicine was included.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Bone Neoplasms; Sarcoma; Neoplasms; Osteosarcoma; Sarcoma, Ewing

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Study Officials

• Lu Xie, M.D.

  Musculoskeletal Tumor Center of Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 11, 2024
• Study Start: November 25, 2021
• Primary Completion: August 29, 2023
• Study Completion: November 15, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)