Bone SarcomaNCT06202599
Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance
An observational study of Bone Sarcoma and Soft Tissue Sarcoma, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Sarcoma, Soft Tissue Sarcoma, Refractory Tumor
- What is being tested?
- Fruquintinib
- Type of treatment
- Pill or oral medicine
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2021to 15 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Failure to complete regular follow-up after administration.
- Discontinued the fruquintinib-based treatment due to neither progression nor unacceptable toxicity.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance:A Multicenter Retrospective Study
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.
Read the 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.
- Conditions
- Bone Sarcoma, Soft Tissue Sarcoma, Refractory Tumor
- Being tested
- Fruquintinib
- Keywords
- Fruquintinib, Osteosarcoma, Ewing sarcoma, Soft Tissue Sarcomas, TKIs
- Medical subject headings
- Bone Neoplasms, Sarcoma, Neoplasms, Osteosarcoma, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
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 | Role | What they receive |
|---|---|---|
| Study group | Fruquintinib treatment group Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The time from the first administration of fruquintinib to the date of first documentation of disease progression or death, whichever occurred first.
Measured: 4months
Secondary outcomes (4)
OS
OS was calculated from the use of fruquintinib until death from any cause
Measured: 1year
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.
Measured: 1year
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.
Measured: 1year
AEs
AEs were graded and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE ) version 5.0.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start25 Nov 2021
- Primary completion29 Aug 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone SarcomaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Lu, Peking University People's Hospital
- Investigators
- Lu Xie, M.D., Principal investigator, Musculoskeletal Tumor Center of Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202599
- Sponsor's protocol ID
- PKUPH-sarcoma 17
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance:A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06202599
- Acronym / sponsor ID
- PKUPH-sarcoma 17
- Conditions
- Bone Sarcoma, Soft Tissue Sarcoma, Refractory Tumor
- Keywords
- Fruquintinib, Osteosarcoma, Ewing sarcoma, Soft Tissue Sarcomas, TKIs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: FruquintinibFruquintinib treatment group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- Failure to complete regular follow-up after administration.
- Discontinued the fruquintinib-based treatment due to neither progression nor unacceptable toxicity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FruquintinibFor 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. | Drug | Study group |
Primary outcome
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.
4 secondary outcomes
OS
Time frame: 1year
ORR
Time frame: 1year
DCR
Time frame: 1year
AEs
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Xie, M.D. principal investigator
Musculoskeletal Tumor Center of Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Sarcoma and Soft Tissue Sarcoma, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 4months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.