OsteosarcomaPhase 2NCT06125171
Tucidinostat Plus Apatinib for Advanced Osteosarcoma
A Phase 2 study testing Tucidinostat, Apatinib in people with Osteosarcoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
This phase II study was designed to assess the efficacy and safety of the combination of Apatinib, Tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or refractory osteosarcoma patients. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Tucidinostat, Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2025
- Phase
- Phase 2
- 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥10 years, ≤ 75 years;
- Histologically confirmed Advanced classic osteosarcoma with unresectable recurrence or metastatic disease ；
- Prior treatment consisted of standard chemotherapy agents including doxorubicin, cisplatin, methotrexate, and ifosfamide;
- Eastern Collaborative Oncology Group (ECOG) 0~2；
- Tumor size is measurable according to RECIST1.1 criteria；
- Adequate organ function；
- Life expectancy is more than 3 months；
- Willing and able to provide written informed consent.
Who cannot join
- Previously exposed to histone deacetylase inhibitors or angiogenesis inhibitors;
- Urine protein≥ ++;
- FBG>10mmol/L;
- Uncontrolled blodd pressure (ystolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg);
- Known active CNS metastases and/or carcinomatous meningitis;
- Not able to take medicine orally;
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- Coagulant function abnormality (PT>16s, APTT> 43s, TT>21s, FIB）<2g/L);
- Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease;
- Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
About this study
Official title: A Phase II Clinical Trial of Tucidinostat in Combination With Apatinib in Patients With Relapsed or Refractory Osteosarcoma
This phase II study was designed to assess the efficacy and safety of the combination of Apatinib, Tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or refractory osteosarcoma patients.
- Conditions
- Osteosarcoma
- Being tested
- Tucidinostat, Apatinib
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tucidinostat, ApatinibDrug
Tucidinostat:
age≥18years, 30mg, po., biw, q4w; age≥10years，<18years，0.5mg/kg, biw, q4w
Apatinib:
BSA≥1.2m^2, 500mg, qd, q4w BSA<1.2m^2, 250mg, qd, q4w
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat+Apatinib | Experimental | Not described Receives: Drug: Tucidinostat, Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression-free survival rate
The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the treatment
Measured: 6 months
Secondary outcomes (4)
Progression-free survival(PFS)
Time from treatment until disease progression or death
Measured: 2 years
Objective Response Rate（ORR）
Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
Measured: 2 years
Disease Control Rate （DCR）
the total proportion of patients with complete response（CR）, partial response（PR）and stable disease（SD）
Measured: 2 years
Overall survival(OS)
Time from treatment until death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125171
- Sponsor's protocol ID
- CSIIT-Q54
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 9 Nov 2023
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Tucidinostat in Combination With Apatinib in Patients With Relapsed or Refractory Osteosarcoma
- ClinicalTrials.gov ID
- NCT06125171
- Acronym / sponsor ID
- CSIIT-Q54
- Conditions
- Osteosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Nov 2023 (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 phase II study was designed to assess the efficacy and safety of the combination of Apatinib, Tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or refractory osteosarcoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucidinostat+Apatinib | Experimental | Drug: Tucidinostat, Apatinib |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥10 years, ≤ 75 years;
- Histologically confirmed Advanced classic osteosarcoma with unresectable recurrence or metastatic disease ；
- Prior treatment consisted of standard chemotherapy agents including doxorubicin, cisplatin, methotrexate, and ifosfamide;
- Eastern Collaborative Oncology Group (ECOG) 0~2；
- Tumor size is measurable according to RECIST1.1 criteria；
Key exclusion criteria (9 listed)
- Previously exposed to histone deacetylase inhibitors or angiogenesis inhibitors;
- Urine protein≥ ++;
- FBG>10mmol/L;
- Uncontrolled blodd pressure (ystolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg);
- Known active CNS metastases and/or carcinomatous meningitis;
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 |
|---|---|---|
| Tucidinostat, ApatinibTucidinostat: age≥18years, 30mg, po., biw, q4w; age≥10years，<18years，0.5mg/kg, biw, q4w Apatinib: BSA≥1.2m^2, 500mg, qd, q4w BSA<1.2m^2, 250mg, qd, q4w | Drug | Tucidinostat+Apatinib |
Primary outcome
6-month progression-free survival rate
Time frame: 6 months
The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the treatment
4 secondary outcomes
Progression-free survival(PFS)
Time frame: 2 years
Objective Response Rate（ORR）
Time frame: 2 years
Disease Control Rate （DCR）
Time frame: 2 years
Overall survival(OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tucidinostat, Apatinib in people with Osteosarcoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
6-month progression-free survival rate (time frame: 6 months). 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 9 Nov 2023.