MedTrace Logo

Irinotecan Liposomes Combined with Temozolomide and Vincristine in the Treatment of Pediatric Patients with Solid Tumors

NCT06710821 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-29

No results posted yet for this study

Summary

A prospective, single-center Ia/Ib clinical study divided into two parts, including Phase Ia Dose Exploration and Phase Phase Ib Extension Phase.

Conditions

  • Solid Tumor Cancer

Interventions

DRUG

Liposomal irinotecan in combination with vincristine and temozolomide

Vincristine: 1.5 mg/m², iv, d1. l Temozolomide 150 mg/m²/d, iv drip, d1-5. l Irinotecan liposomal RP dose, iv infusion over 90 min, d1. Q3W, 4 cycles expected until disease progression or intolerable toxicity occurs

Sponsors & Collaborators

  • Yizhuo Zhang

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-31
Completion
2026-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06710821 on ClinicalTrials.gov