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RecruitingNCT06514313Updated Jul 23, 2024

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

A Phase 2 interventional study of Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine and Temozolomide+Irinotecan+Vincristine in Soft Tissue Sarcoma, sponsored by Yizhuo Zhang. Recruiting at 1 site in China. Open to participants aged 2 Years to 21 Years. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Yizhuo Zhang · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
2 Years to 21 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Soft Tissue Sarcoma

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03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's planned enrollment of 110 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Yizhuo Zhang is the lead sponsor of 8 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    VIM

    Mitoxantrone Hydrochloride Liposome combined with Irinotecan and Vincristine.

    Drug: Mitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine

  • Active comparator
    VIT

    Temozolomide combined with Irinotecan and Vincristine.

    Drug: Temozolomide+Irinotecan+Vincristine

Interventions

  • DrugMitoxantrone Hydrochloride Liposome+Irinotecan+Vincristine

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

  • DrugTemozolomide+Irinotecan+Vincristine

    Q3W, 4 cycles

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Up to 2 cycles of chemotherapy (each cycle is 21 days)

Secondary outcomes

  1. 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)

    Time frame: Up to 4 cycles of chemotherapy (each cycle is 21 days)

  2. Disease control rate (DCR)

    Refers to the percentage of patients with confirmed complete response, partial response, and disease stability in patients with evaluable efficacy

    Time frame: Up to 4 cycles of chemotherapy (each cycle is 21 days)

  3. 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.

    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.

  4. Overall survival (OS)

    Overall survival (OS) was defined from the date of enrollment to the date of death from any cause.

    Time frame: From date of radomization unit the date of first documented date of death from any cause, assessed up to 24 moths

Other outcomes

  1. Circulating tumor DNA (ctDNA) .

    ctDNA was dynamically monitored and the correlation between ctDNA and efficacy was evaluated.

    Time frame: Assessed up to 24 moths.

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06514313
Lead sponsor
Yizhuo Zhang
Responsible party
Yizhuo Zhang (Director, Sun Yat-sen University) — Sponsor-investigator
First posted
Jul 23, 2024
Start date
Jul 3, 2024
Primary completion
Aug 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jul 23, 2024

Study contacts

Yizhuo Zhang, PhD
Contact
zhangyzh@sysucc.org.cn
020-87342460

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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