OsteosarcomaPhase 2NCT06217003
Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma
A Phase 2 study testing Trilaciclib in people with Osteosarcoma, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
This study is a prospective, single arm phase II study aimed at evaluating the efficacy and safety of trilaciclib before perioperative chemotherapy in patients with osteosarcoma. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Trilaciclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Aug 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 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12 years old ≤ Age ≤ 50 years old, regardless of gender;
- Patients diagnosed by pathology and evaluated by surgeons as having unmetastased resectable osteosarcoma
- The patient's laboratory test meets the standards
- Cardiac echocardiography must meet the following criteria: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).
- ECOG PS score 0-1 points;
- Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and reliable contraceptive measures must be taken 3 months after signing the informed consent form and the last dose;
- Understand and sign the informed consent form.
Who cannot join
- Diagnosed as other malignant diseases outside of osteosarcoma within 5 years prior to initial administration (excluding curative basal cell carcinoma, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ);
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV);
- Stroke or cardiovascular events within 6 months prior to enrollment;
- When screening, QTcF interval>480msec, for patients with implanted ventricular pacemakers, QTcF>500msec
- Previously received hematopoietic stem cell or bone marrow transplantation;
- Allergy to the investigational drug or its components;
- The researchers believe that it is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
About this study
Official title: A Phase II Clinical Study of Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma
This study is a prospective, single arm phase II study aimed at evaluating the efficacy and safety of trilaciclib before perioperative chemotherapy in patients with osteosarcoma.
Read the detailed description
This study is a prospective, single arm phase II study aimed at evaluating the efficacy and safety of Trilaciclib before perioperative chemotherapy in patients with osteosarcoma.Patients diagnosed by pathology and evaluated by surgeons as having non metastatic resectable osteosarcoma, after signing informed consent, will be screened for eligible subjects to receive a treatment regimen of tralazilide before perioperative chemotherapy;
The study will include 20 participants who will receive the following design scheme:
During the preoperative neoadjuvant therapy period, the subjects will receive two cycles of preoperative neoadjuvant therapy:Trilaciclib is administered daily within 4 hours before chemotherapy, 240mg/m2, intravenously; The chemotherapy regimen is MAP regimen (doxorubicin 75mg/m2, cisplatin 120mg/m2, methotrexate 8-12g/m2); Recombinant human endostatin: 210 mg, CIV 72 hours, administration method: continuous intravenous infusion, starting from the first day of each cycle; The subject underwent preoperative imaging evaluation and surgical indication evaluation one week after the end of the last medication before surgery. Subjects who still have indications for surgery after completing the two cycles before neoadjuvant therapy will receive surgical treatment within one week.
One week after surgery, the subjects began to receive a combination of trilaciclib chemotherapy (MAP regimen) and recombinant human endostatin adjuvant therapy for four cycles; Monitor adverse events (AE) throughout the entire study process and assess their severity level according to the guidelines listed in the National Cancer Institute (NCI) Common Terminology Standards for Adverse Events (CTCAE) version 5.0 or higher. Safety follow-up will be conducted on subjects receiving study treatment and early discontinuation of medication. The total survival of all subjects will be followed up until death, withdrawal of informed consent, or end of the study.
- Conditions
- Osteosarcoma
- Being tested
- Trilaciclib
- Keywords
- Osteosarcoma, Perioperative period, Trilaciclib, Chemotherapy
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrilaciclibDrug
Preoperative application of trilaciclib during perioperative chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| trilaciclib | Experimental | Screening of eligible subjects for inclusion and application of trilaciclib before undergoing perioperative chemotherapy Receives: Drug: Trilaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade ≥ 3 neutropenia during chemotherapy treatment
Is the number of neutrophils in the blood routine test lower than the ninth power of 1.0 * 10/L
Measured: 1-2 weeks after chemotherapy
Secondary outcomes (3)
The incidence of grade 4 neutropenia during chemotherapy treatment
Is the number of neutrophils in the blood routine test lower than the ninth power of 0.5 * 10/L
Measured: 1-2 weeks after chemotherapy
The occurrence of grade 3 or grade 4 thrombocytopenia during chemotherapy treatment
Is the number of platelet in the blood routine test lower than the ninth power of 50 or 25 * 10/L
Measured: 1-3 weeks after chemotherapy
The incidence of grade 3 or 4 anemia during chemotherapy treatment
Is the number of hemoglobin in the blood routine test lower than 80g/L
Measured: 1-3 weeks after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Aug 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217003
- Sponsor's protocol ID
- HSKY028
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared mid-term data analysis report and final data analysis after patient enrollment
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma
- ClinicalTrials.gov ID
- NCT06217003
- Acronym / sponsor ID
- HSKY028
- Conditions
- Osteosarcoma
- Keywords
- Osteosarcoma, Perioperative period, Trilaciclib, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 22 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 study is a prospective, single arm phase II study aimed at evaluating the efficacy and safety of trilaciclib before perioperative chemotherapy in patients with osteosarcoma.
Detailed description
This study is a prospective, single arm phase II study aimed at evaluating the efficacy and safety of Trilaciclib before perioperative chemotherapy in patients with osteosarcoma.Patients diagnosed by pathology and evaluated by surgeons as having non metastatic resectable osteosarcoma, after signing informed consent, will be screened for eligible subjects to receive a treatment regimen of tralazilide before perioperative chemotherapy;
The study will include 20 participants who will receive the following design scheme:
During the preoperative neoadjuvant therapy period, the subjects will receive two cycles of preoperative neoadjuvant therapy:Trilaciclib is administered daily within 4 hours before chemotherapy, 240mg/m2, intravenously; The chemotherapy regimen is MAP regimen (doxorubicin 75mg/m2, cisplatin 120mg/m2, methotrexate 8-12g/m2); Recombinant human endostatin: 210 mg, CIV 72 hours, administration method: continuous intravenous infusion, starting from the first day of each cycle; The subject underwent preoperative imaging evaluation and surgical indication evaluation one week after the end of the last medication before surgery. Subjects who still have indications for surgery after completing the two cycles before neoadjuvant therapy will receive surgical treatment within one week.
One week after surgery, the subjects began to receive a combination of trilaciclib chemotherapy (MAP regimen) and recombinant human endostatin adjuvant therapy for four cycles; Monitor adverse events (AE) throughout the entire study process and assess their severity level according to the guidelines listed in the National Cancer Institute (NCI) Common Terminology Standards for Adverse Events (CTCAE) version 5.0 or higher. Safety follow-up will be conducted on subjects receiving study treatment and early discontinuation of medication. The total survival of all subjects will be followed up until death, withdrawal of informed consent, or end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trilaciclib | Experimental | Drug: TrilaciclibScreening of eligible subjects for inclusion and application of trilaciclib before undergoing perioperative chemotherapy |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 12 years old ≤ Age ≤ 50 years old, regardless of gender;
- Patients diagnosed by pathology and evaluated by surgeons as having unmetastased resectable osteosarcoma
- The patient's laboratory test meets the standards
- Cardiac echocardiography must meet the following criteria: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).
- ECOG PS score 0-1 points;
Key exclusion criteria (7 listed)
- Diagnosed as other malignant diseases outside of osteosarcoma within 5 years prior to initial administration (excluding curative basal cell carcinoma, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ);
- Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV);
- Stroke or cardiovascular events within 6 months prior to enrollment;
- When screening, QTcF interval>480msec, for patients with implanted ventricular pacemakers, QTcF>500msec
- Previously received hematopoietic stem cell or bone marrow transplantation;
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 |
|---|---|---|
| TrilaciclibPreoperative application of trilaciclib during perioperative chemotherapy | Drug | trilaciclib |
Primary outcome
The incidence of grade ≥ 3 neutropenia during chemotherapy treatment
Time frame: 1-2 weeks after chemotherapy
Is the number of neutrophils in the blood routine test lower than the ninth power of 1.0 * 10/L
3 secondary outcomes
The incidence of grade 4 neutropenia during chemotherapy treatment
Time frame: 1-2 weeks after chemotherapy
The occurrence of grade 3 or grade 4 thrombocytopenia during chemotherapy treatment
Time frame: 1-3 weeks after chemotherapy
The incidence of grade 3 or 4 anemia during chemotherapy treatment
Time frame: 1-3 weeks after chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Yes. Shared mid-term data analysis report and final data analysis after patient enrollment
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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.
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 in people with Osteosarcoma, run by The First Affiliated Hospital of Xinxiang Medical College 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 7 inclusion and 7 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 22 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.
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?
The incidence of grade ≥ 3 neutropenia during chemotherapy treatment (time frame: 1-2 weeks after chemotherapy). 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 22 Jan 2024.