NCT07444918Not yet recruitingPhase 2
Liposomal Irinotecan, Vincristine, Temozolomide, and Anlotinib for R/R Pediatric Solid Tumors
A Prospective, Single-Center, Single-Arm Study to Evaluate the Efficacy and Safety of Liposomal Irinotecan, Vincristine, and Temozolomide With or Without Anlotinib in Children and Adolescents With Relapsed or Refractory Malignant Solid Tumors
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
This is a prospective, single-center, single-arm interventional trial conducted at Tianjin Medical University Cancer Institute and Hospital. It evaluates the efficacy and safety of a combination regimen (liposomal irinotecan + vincristine + temozolomide ± anlotinib) in children with relapsed or refractory malignant solid tumors, with the goal of optimizing regimen-related adverse reactions and exploring appropriate administration strategies. 1. Study Objectives Primary Objective: Assess the objective response rate (ORR) of the combination regimen in the study population. Secondary Objectives: Evaluate survival outcomes (progression-free survival \[PFS\], overall survival \[OS\]) and the incidence of adverse events (per NCI CTCAE v5.0). 2. Eligibility Criteria Inclusion Criteria Aged 3-18 years (inclusive) at consent; Pathologically confirmed relapsed or refractory malignant solid tumors (e.g., neuroblastoma, rhabdomyosarcoma); At least one measurable lesion (per RECIST v1.1); Adequate functional status and organ function (per institutional standards); Written informed consent from subject/legal guardian. Exclusion Criteria Hypersensitivity to study drugs; Active uncontrolled infection or severe comorbidities; Concurrent participation in other interventional trials; Conditions precluding study participation (per investigator judgment). 3. Intervention Procedures Eligible subjects are assigned to short-course or long-course subgroups based on clinical status: Short-course: Liposomal irinotecan (Day 1), vincristine (Day 1), temozolomide (Days 1-5), ± weight-based anlotinib (Days 1-14); Long-course: Liposomal irinotecan (Days 1/8/15), plus the same doses of other drugs as the short-course subgroup. Each treatment cycle is 21 days. Efficacy is assessed regularly; treatment (dose/subgroup) will be adjusted per clinical condition. 4. Outcome Assessments Primary Outcome: ORR (assessed per RECIST v1.1 at regular intervals); Secondary Outcomes: PFS, OS (long-term follow-up post-treatment), and adverse event incidence. 5. Participant Requirements Participation is voluntary. Subjects/guardians must provide written informed consent prior to enrollment. Long-term follow-up will be conducted post-treatment.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Neuroblastoma, Childhood cancers, Sarcoma
- NCT number
- NCT07444918
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 1 Mar 2026 to the primary completion date, 1 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active systemic infection requiring systemic antibiotic treatment within 7 days prior to enrollment.
- Concurrent participation in another interventional clinical trial.
Other illness
- Known hypersensitivity to any component of the study drugs (liposomal irinotecan, vincristine, temozolomide, anlotinib).
- History of severe cardiovascular disease (e.g., congestive heart failure, uncontrolled arrhythmia).
- Other medical conditions that, in the investigator's judgment, may affect study participation or outcome assessment.
Other
- Pregnancy, lactation, or unwillingness to use effective contraception (for sexually active subjects).
Who the study is looking for
- 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).
Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.