Soft Tissue SarcomaPhase 2NCT06514313
Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.
A Phase 2 study testing Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine and Temozolomide+Irinotecan+Vincristine in people with Soft Tissue Sarcoma, run by Yizhuo Zhang at 1 site in China.
Trial summary
Explore the efficacy and safety of mitoxantrone liposome combined with irinotecan and vincristine (VIM) in the treatment of relapsed/refractory soft tissue sarcoma in children. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine and Temozolomide+Irinotecan+Vincristine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2024to 1 Dec 2026
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 2 years ≤age≤21 years, no gender limitation.
- The Karnofsky (≥16 years old) or Lansky (< 16 years old) physical status score is at least 70.
- The expected survival time is not less than 12 weeks.
- Heart function: a) Cardiac COLOR ultrasound detection LVEF≥ 50%; b) ECG suggests no myocardial ischemia; c) No history of arrhythmia requiring drug intervention before enrollment.
- Pathological results for patients of soft tissue sarcoma.
- Patients with rhabdomyosarcoma are limited to first -, second -, and third-line treatment, and patients with other pathological subtypes are limited to progression, recurrence, or refractory after first-line treatment, with refractory defined as failure to achieve complete or partial response to the most recent treatment.
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- Measurable lesions (according to RECIST 1.1 standards, measurable lesions have not received radiotherapy, freezing and other local treatments).
- The patient must fully recover from the acute toxic effects of all previous anticancer chemotherapy.
- Good blood and organ function.
- During study participation, patients are able to adhere to outpatient treatment, laboratory monitoring, and necessary clinical visits.
- The parent/guardian of the child or adolescent subject is capable of understanding, agreeing to, and signing the study Informed consent (ICF) and the applicable child consent form prior to initiating any program-related procedures; Subject is capable of expressing consent with parental/guardian consent (if applicable).
Who cannot join
- Once received mitoxantrone or mitoxantrone liposomes.
- Patients who had received previous VIT (irinotecan + temozolomide + vincristine) chemotherapy.
- Previous treatment with adriamycin or other anthracyclines with a total cumulative dose of adriamycin > 360 mg/m^2; Or patients with cardiac disease caused by previous anthracyclines.
- Receiving or not being able to discontinue P450 enzyme-induced anticonvulsant drugs (e.g., phenytoin, carbamazepine, etc.) within 4 weeks or 5 half-life periods prior to enrollment.
- Previous or concurrent clinical significance of active cardiovascular diseases.
- Severe chronic skin diseases in the past.
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- Previous allergic asthma or severe allergic disease.
- Uncontrolled hypertension and diabetes.
- Have a history of other tumors, except cured cervical cancer or basal cell carcinoma of the skin.
- Active hepatitis B or hepatitis C infection.
- HIV or syphilis infected patients.
- Patients who have previously received organ transplants.
- Uncontrolled active systemic bacterial, viral, or fungal infection.
- Contraindications to high-dose hormone use, such as uncontrolled hyperglycemia, gastric ulcers, or psychiatric disorders.
- Severe neurological or psychiatric history, including epilepsy or autism.
- Pregnant, lactating women and patients of childbearing age who are unwilling to use contraception.
- Other circumstances deemed inappropriate by the investigator to participate in the study.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yi-Zhuo Zhang, MD, 87342460, zhangyzh@sysucc.org.cn
About this study
Official title: Phase II Randomized Controlled Clinical Trial of Mitoxantrone Hydrochloride Liposome Combined With Irinotecan and Vincristine (VIM) With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.
Explore the efficacy and safety of mitoxantrone liposome combined with irinotecan and vincristine (VIM) in the treatment of relapsed/refractory soft tissue sarcoma in children.
Read the detailed description
Children with relapsed/refractory soft tissue sarcoma who meet the inclusion criteria are randomly divided into VIM group and VIT group (irinotecan, vincristine, temozolomide) at 1:1. The efficacy and safety of the two groups are compared.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine, Temozolomide+Irinotecan+Vincristine
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride Liposome+Irinotecan+VincristineDrug
Mitoxantrone hydrochloride liposome will be administered by an intravenous infusion , 4 cycles.
Temozolomide+Irinotecan+VincristineDrug
Q3W, 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| VIM | Experimental | Mitoxantrone Hydrochloride Liposome combined with Irinotecan and Vincristine. Receives: Drug: Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine |
| VIT | Active comparator | Temozolomide combined with Irinotecan and Vincristine. Receives: Drug: Temozolomide+Irinotecan+Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate (ORR) after 2 cycles of chemotherapy with VIM or VIT regimen, including complete response (CR) and partial response (PR)
Measured: Up to 2 cycles of chemotherapy (each cycle is 21 days)
Secondary outcomes (4)
Objective response rate (ORR)
Objective response rate (ORR) after 4 cycles of chemotherapy with VIM or VIT regimen, including complete response (CR) and partial response (PR)
Measured: Up to 4 cycles of chemotherapy (each cycle is 21 days)
Disease control rate (DCR)
Refers to the percentage of patients with confirmed complete response, partial response, and disease stability in patients with evaluable efficacy
Measured: Up to 4 cycles of chemotherapy (each cycle is 21 days)
Progression-free survival (PFS)
Means from the date of enrollment to the date of first disease progression or death from any cause, whichever comes first. If the subject has no disease progression during the trial period, PFS is defined as the last date until the subject's last confirmed progression-free survival.
Measured: From date of radomization unit the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 moths.
Overall survival (OS)
Overall survival (OS) was defined from the date of enrollment to the date of death from any cause.
Measured: From date of radomization unit the date of first documented date of death from any cause, assessed up to 24 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start3 Jul 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yizhuo Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yizhuo Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514313
- Sponsor's protocol ID
- CSPC-DED-STS-K01
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 23 Jul 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Controlled Clinical Trial of Mitoxantrone Hydrochloride Liposome Combined With Irinotecan and Vincristine (VIM) With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.
- ClinicalTrials.gov ID
- NCT06514313
- Acronym / sponsor ID
- CSPC-DED-STS-K01
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Yizhuo ZhangUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Jul 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.
Explore the efficacy and safety of mitoxantrone liposome combined with irinotecan and vincristine (VIM) in the treatment of relapsed/refractory soft tissue sarcoma in children.
Detailed description
Children with relapsed/refractory soft tissue sarcoma who meet the inclusion criteria are randomly divided into VIM group and VIT group (irinotecan, vincristine, temozolomide) at 1:1. The efficacy and safety of the two groups are compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIM | Experimental | Drug: Mitoxantrone Hydrochloride Liposome+Irinotecan+VincristineMitoxantrone Hydrochloride Liposome combined with Irinotecan and Vincristine. |
| VIT | Active comparator | Drug: Temozolomide+Irinotecan+VincristineTemozolomide combined with Irinotecan and Vincristine. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 2 years ≤age≤21 years, no gender limitation.
- The Karnofsky (≥16 years old) or Lansky (< 16 years old) physical status score is at least 70.
- The expected survival time is not less than 12 weeks.
- Heart function: a) Cardiac COLOR ultrasound detection LVEF≥ 50%; b) ECG suggests no myocardial ischemia; c) No history of arrhythmia requiring drug intervention before enrollment.
- Pathological results for patients of soft tissue sarcoma.
Key exclusion criteria (17 listed)
- Once received mitoxantrone or mitoxantrone liposomes.
- Patients who had received previous VIT (irinotecan + temozolomide + vincristine) chemotherapy.
- Previous treatment with adriamycin or other anthracyclines with a total cumulative dose of adriamycin > 360 mg/m^2; Or patients with cardiac disease caused by previous anthracyclines.
- Receiving or not being able to discontinue P450 enzyme-induced anticonvulsant drugs (e.g., phenytoin, carbamazepine, etc.) within 4 weeks or 5 half-life periods prior to enrollment.
- Previous or concurrent clinical significance of active cardiovascular diseases.
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 |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome+Irinotecan+VincristineMitoxantrone hydrochloride liposome will be administered by an intravenous infusion , 4 cycles. | Drug | VIM |
| Temozolomide+Irinotecan+VincristineQ3W, 4 cycles | Drug | VIT |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 2 cycles of chemotherapy (each cycle is 21 days)
Objective response rate (ORR) after 2 cycles of chemotherapy with VIM or VIT regimen, including complete response (CR) and partial response (PR)
4 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 4 cycles of chemotherapy (each cycle is 21 days)
Disease control rate (DCR)
Time frame: Up to 4 cycles of chemotherapy (each cycle is 21 days)
Progression-free survival (PFS)
Time frame: From date of radomization unit the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 moths.
Overall survival (OS)
Time frame: From date of radomization unit the date of first documented date of death from any cause, assessed up to 24 moths
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 23 Jul 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.
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 Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine and Temozolomide+Irinotecan+Vincristine in people with Soft Tissue Sarcoma, run by Yizhuo Zhang 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 11 inclusion and 17 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 23 Jul 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?
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?
Contact Yizhuo Zhang, PhD (020-87342460, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 2 cycles of chemotherapy (each cycle is 21 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 23 Jul 2024.