Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma.

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.

Clinical Trial of VIM With VIT in Children With Relapsed and Refractory Soft Tissue Sarcoma. (NCT06514313) is a Phase 2 interventional studying Soft Tissue Sarcoma, sponsored by Yizhuo Zhang. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Soft Tissue Sarcoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 110 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Soft Tissue Sarcoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - 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 willing to sign a consent form (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 Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. * 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). Exclusion Criteria: * 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. * 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.

Treatments Being Tested

DRUG

Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine

Mitoxantrone hydrochloride liposome will be administered by an intravenous infusion , 4 cycles.

DRUG

Temozolomide+Irinotecan+Vincristine

Q3W, 4 cycles

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06514313), the sponsor (Yizhuo Zhang), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06514313 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06514313?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06514313?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06514313. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06514313. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.