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New hope for kids with tough cancers: drug combo trial launches

NCT ID NCT07444918

Disease control Sponsor: Tianjin Medical University Cancer Institute and Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of chemotherapy drugs (liposomal irinotecan, vincristine, and temozolomide) with or without an additional drug (anlotinib) in children aged 3-18 whose solid tumors have returned or not responded to treatment. The goal is to see if this combination can shrink tumors and control the disease, while monitoring side effects. About 33 participants will receive treatment in 21-day cycles, with regular check-ups to track progress.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 33 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 3 to 18 years (inclusive) at the time of informed consent signing. * Pathologically confirmed relapsed or refractory malignant solid tumors (including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, osteosarcoma). * At least one measurable lesion (as defined by RECIST v1.1) confirmed by CT/MRI within 28 days prior to enrollment. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. * Adequate organ function (absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥90g/L; serum creatinine ≤1.5×upper limit of normal \[ULN\] for age; total bilirubin ≤1.5×ULN; alanine aminotransferase/aspartate aminotransferase ≤2.5×ULN, or ≤5×ULN if liver metastasis exists). * Written informed consent provided by the subject (if ≥18 years old) or legal guardian (if \<18 years old). Exclusion Criteria: * Known hypersensitivity to any component of the study drugs (liposomal irinotecan, vincristine, temozolomide, anlotinib). * Active systemic infection requiring systemic antibiotic treatment within 7 days prior to enrollment. * History of severe cardiovascular disease (e.g., congestive heart failure, uncontrolled arrhythmia). * Concurrent participation in another interventional clinical trial. * Pregnancy, lactation, or unwillingness to use effective contraception (for sexually active subjects). * Other medical conditions that, in the investigator's judgment, may affect study participation or outcome assessment.

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Conditions

The condition(s) this trial relates to.

childhood malignant neoplasm Ewing sarcoma neuroblastoma osteosarcoma Recurrence refractory malignant neoplasm rhabdomyosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed or refractory pediatric malignant solid tumors (including neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, osteosarcoma)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.