OsteosarcomaPhase 2NCT06714383
Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma
A Phase 2 study testing Trilaciclib, Pirarubicin and Lobaplatin in people with Osteosarcoma, run by Peking University People's Hospital at 1 site in China.
Trial summary
To evaluate the clinical application value in bone marrow protection of Trilaciclib in the neoadjuvant treatment of stage II/III classic osteosarcoma in combination with pirarubicin and lobaplatin. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Trilaciclib, Pirarubicin and Lobaplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2024to Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent signed;
- Classic osteosarcoma confirmed by histopathology (high grade);
- Newly diagnosed stage Ⅱ-Ⅲ based on Enneking staging criteria;
- Planned to receive neoadjuvant chemotherapy;
- Measurable disease on CT by RECIST 1.1.
- No antitumor system therapy received;
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- ECOG 0-1
- Adequate organ function.
- Females of childbearing potential as well as males and their partners must agree to use an effective form of contraception during the study and for 6 months following the last dose of study medication.
Who cannot join
- History of malignancies of other type;
- Allergic to study agent;
- History of psychotropic substance abuse, alcohol or drug use;
- The researchers considered inappropriate to join the study of any cause.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100000
Xin Sun, +86 13810548607, margoshelly@hotmail.com
About this study
Official title: A Prospective Randomized Phase Ⅱ Study of Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma
To evaluate the clinical application value in bone marrow protection of Trilaciclib in the neoadjuvant treatment of stage II/III classic osteosarcoma in combination with pirarubicin and lobaplatin.
Read the detailed description
Classic osteosarcoma is the most common primary bone malignancy. At present, osteosarcoma is usually treated with preoperative chemotherapy, surgical operation and postoperative chemotherapy. Treatment with preoperative chemotherapy is also known as neoadjuvant chemotherapy. Neoadjuvant chemotherapy has brought benefits to patients, but safety concerns are inevitable. Myelosuppression is a major factor affecting the compliance of patients treated by chemotherapy. Patients with chemotherapy-induced myelosuppression(CIM) have higher rates of infection, sepsis, bleeding, and fatigue, resulting in hospitalization, hematopoietic growth factor support, blood transfusions (red blood cells and/or platelets) and even death. In addition, CIM often leads to dose reduction and delayed administration, which limits the therapeutic dose intensity and therefore affects the anti-tumor efficacy of chemotherapy.
Currently, there are no approved treatments in osteosarcoma to prevent chemotherapy-induced cell damage. Although some treatments may help to address CIM when it occurs such as blood transfusions and growth factors, these treatments are pedigree specific, being used after hematopoietic stem progenitor cells damage and could bring additional toxicity.
Trilaciclib is a highly effective, selective and temporarily reversible inhibitor of CDK4/6. The proliferation of bone marrow hematopoietic stem cells depends on CDK4/6 activity. Bone marrow hematopoietic stem cells are blocked in the G1 phase of the cell cycle after exposure to Trilaciclib before chemotherapy is given.
Therefore, this study is conducted to evaluate the clinical application value in bone marrow protection of Trilaciclib in the neoadjuvant treatment of stage II/III classic osteosarcoma in combination with pirarubicin and lobaplatin.
- Conditions
- Osteosarcoma
- Being tested
- Trilaciclib, Pirarubicin, Lobaplatin
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
Also called Cosela
Trilaciclib: 240mg/m2, IV, within 4 hours before each chemotherapy agent infused.
PirarubicinDrug
Pirarubicin: 60 mg/m2，IV，d1-2
LobaplatinDrug
LobaplLatin: 40 mg/m2,，IV，d1
| Study group | Role | What they receive |
|---|---|---|
| Trilaciclib Arm | Experimental | Neoadjuvant therapy of adding Trilaciclib to Pirarubicin and Lobaplatin Receives: Drug: Trilaciclib; Drug: Pirarubicin; Drug: Lobaplatin |
| Control Arm | Sham comparator | Neoadjuvant therapy of Pirarubicin and Lobaplatin Receives: Drug: Pirarubicin; Drug: Lobaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3/4 neutropenia
Incidence of grade 3/4 neutropenia up to 30 days
Measured: up to 30 days
Secondary outcomes (14)
Duration of grade 3/4 neutropenia
Duration of grade 3/4 neutropenia up to 30 days
Measured: up to 30 days
Incidence of grade 3/4 thrombocytopenia
Incidence of grade 3/4 thrombocytopenia up to 30 days
Measured: up to 30 days
Incidence of grade 3 or 4 anemia
Incidence of grade 3 or 4 anemia up to 30 days
Measured: up to 30 days
Incidence of febrile neutropenia
Incidence of febrile neutropenia up to 30 days
Measured: up to 30 days
Usage of granulocyte colony-stimulating factor (G-CSF)
Utilization rate of granulocyte colony-stimulating factor (G-CSF) up to 30 days
Measured: up to 30 days
Usage of Thrombopoietin (TPO)
Utilization rate of Thrombopoietin (TPO) up to 30 days
Measured: up to 30 days
Usage of Erythropoietin (ESA)
Utilization rate of Erythropoietin (ESA) up to 30 days
Measured: up to 30 days
Incidence of platelet transfusion
Incidence of platelet transfusion up to 30 days
Measured: up to 30 days
Incidence of red blood cell transfusion
Incidence of red blood cell transfusion up to 30 days
Measured: up to 30 days
Usage of ferralia
Utilization rate of ferralia up to 30 days
Measured: up to 30 days
chemotherapy dose reduction of any cause
chemotherapy dose reduction rate of any cause up to 30 days
Measured: up to 30 days
AE adverse event adverse event adverse event
adverse event
Measured: up to 30 days
SAE
serious adverse event serious adverse event serious adverse event Serious Adverse Event
Measured: up to 30 days
Termination of treatment caused by AE/SAE
Termination of treatment rate caused by AE/SAE
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start13 Nov 2024
- Primary completionJul 2025 (estimated)
- Study completionNov 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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Xiaodong, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714383
- Sponsor's protocol ID
- SMA-OS-001
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Phase Ⅱ Study of Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma
- ClinicalTrials.gov ID
- NCT06714383
- Acronym / sponsor ID
- SMA-OS-001
- Conditions
- Osteosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 Dec 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.
To evaluate the clinical application value in bone marrow protection of Trilaciclib in the neoadjuvant treatment of stage II/III classic osteosarcoma in combination with pirarubicin and lobaplatin.
Detailed description
Classic osteosarcoma is the most common primary bone malignancy. At present, osteosarcoma is usually treated with preoperative chemotherapy, surgical operation and postoperative chemotherapy. Treatment with preoperative chemotherapy is also known as neoadjuvant chemotherapy. Neoadjuvant chemotherapy has brought benefits to patients, but safety concerns are inevitable. Myelosuppression is a major factor affecting the compliance of patients treated by chemotherapy. Patients with chemotherapy-induced myelosuppression(CIM) have higher rates of infection, sepsis, bleeding, and fatigue, resulting in hospitalization, hematopoietic growth factor support, blood transfusions (red blood cells and/or platelets) and even death. In addition, CIM often leads to dose reduction and delayed administration, which limits the therapeutic dose intensity and therefore affects the anti-tumor efficacy of chemotherapy.
Currently, there are no approved treatments in osteosarcoma to prevent chemotherapy-induced cell damage. Although some treatments may help to address CIM when it occurs such as blood transfusions and growth factors, these treatments are pedigree specific, being used after hematopoietic stem progenitor cells damage and could bring additional toxicity.
Trilaciclib is a highly effective, selective and temporarily reversible inhibitor of CDK4/6. The proliferation of bone marrow hematopoietic stem cells depends on CDK4/6 activity. Bone marrow hematopoietic stem cells are blocked in the G1 phase of the cell cycle after exposure to Trilaciclib before chemotherapy is given.
Therefore, this study is conducted to evaluate the clinical application value in bone marrow protection of Trilaciclib in the neoadjuvant treatment of stage II/III classic osteosarcoma in combination with pirarubicin and lobaplatin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trilaciclib Arm | Experimental | Drug: Trilaciclib, Drug: Pirarubicin, Drug: LobaplatinNeoadjuvant therapy of adding Trilaciclib to Pirarubicin and Lobaplatin |
| Control Arm | Sham comparator | Drug: Pirarubicin, Drug: LobaplatinNeoadjuvant therapy of Pirarubicin and Lobaplatin |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent signed;
- Classic osteosarcoma confirmed by histopathology (high grade);
- Newly diagnosed stage Ⅱ-Ⅲ based on Enneking staging criteria;
- Planned to receive neoadjuvant chemotherapy;
- Measurable disease on CT by RECIST 1.1.
Key exclusion criteria (4 listed)
- History of malignancies of other type;
- Allergic to study agent;
- History of psychotropic substance abuse, alcohol or drug use;
- The researchers considered inappropriate to join the study of any cause.
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 |
|---|---|---|
| TrilaciclibAlso: CoselaTrilaciclib: 240mg/m2, IV, within 4 hours before each chemotherapy agent infused. | Drug | Trilaciclib Arm |
| PirarubicinPirarubicin: 60 mg/m2，IV，d1-2 | Drug | Control Arm, Trilaciclib Arm |
| LobaplatinLobaplLatin: 40 mg/m2,，IV，d1 | Drug | Control Arm, Trilaciclib Arm |
Primary outcome
Incidence of grade 3/4 neutropenia
Time frame: up to 30 days
Incidence of grade 3/4 neutropenia up to 30 days
14 secondary outcomes
Duration of grade 3/4 neutropenia
Time frame: up to 30 days
Incidence of grade 3/4 thrombocytopenia
Time frame: up to 30 days
Incidence of grade 3 or 4 anemia
Time frame: up to 30 days
Incidence of febrile neutropenia
Time frame: up to 30 days
Usage of granulocyte colony-stimulating factor (G-CSF)
Time frame: up to 30 days
Usage of Thrombopoietin (TPO)
Time frame: up to 30 days
Usage of Erythropoietin (ESA)
Time frame: up to 30 days
Incidence of platelet transfusion
Time frame: up to 30 days
Incidence of red blood cell transfusion
Time frame: up to 30 days
Usage of ferralia
Time frame: up to 30 days
chemotherapy dose reduction of any cause
Time frame: up to 30 days
AE adverse event adverse event adverse event
Time frame: up to 30 days
SAE
Time frame: up to 30 days
Termination of treatment caused by AE/SAE
Time frame: up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trilaciclib, Pirarubicin and Lobaplatin in people with Osteosarcoma, 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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Dec 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3/4 neutropenia (time frame: up to 30 days). 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 3 Dec 2024.