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

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06202599
• Other study ID #: PKUPH-sarcoma 17
• Status: Completed
• Start date: November 25, 2021
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: November 15, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Sarcoma
• Refractory Tumor
• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OS	OS was calculated from the use of fruquintinib until death from any cause	1year
Secondary	ORR	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.	1year
Secondary	DCR	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.	1year
Secondary	AEs	AEs were graded and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE ) version 5.0.	1year