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

Completed

• Conditions: Bone Sarcoma; Soft Tissue Sarcoma; Refractory Tumor
• Interventions: Drug: Fruquintinib

• Registration Number: NCT06202599
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-11-25
• Primary Completion: 2023-08-29
• Study Completion: 2023-11-15
• Study First Submitted: 2023-12-21
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-01
• Study First Posted: 2024-01-11
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Fruquintinib	Fruquintinib treatment group

Primary Outcome Measures

Name	Time	Method
PFS	4months	The time from the first administration of fruquintinib to the date of first documentation of disease progression or death, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
OS	1year	OS was calculated from the use of fruquintinib until death from any cause
ORR	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.
DCR	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.
AEs	1year	AEs were graded and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE ) version 5.0.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China