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NOT YET RECRUITING
NCT06710821
PHASE1

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

Sponsor: Yizhuo Zhang

View on ClinicalTrials.gov

Summary

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

Official title: Phase I Clinical Study of Irinotecan Liposomes in Combination with Temozolomide and Vincristine in the Treatment of Patients with Relapsed/refractory Pediatric Solid Tumors

Key Details

Gender

All

Age Range

12 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-12-01

Completion Date

2026-12-31

Last Updated

2024-11-29

Healthy Volunteers

No

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