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

Sponsor
Yizhuo Zhang
Study ID
NCT06710821
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Solid Tumor Cancer

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Dec 1, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VIT
    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.

Primary Outcome Measure

maximum tolerated dose (MTD) [ Time Frame: 6 months ]

Central Contacts

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