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Study identifier: NCT06760117 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

UGT1A1 Genotype-drien Phase I Study of Irinotecan in VIT Regimen for the Treatment of Pediatric R/R Solid Tumors

Condition: Pediatric Solid Tumor  ·  Sponsor: Sun Yat-sen University

PhasePhase 1
Planned participants39
Who can joinAll sexes, N/A to 18 Years
Healthy volunteersNo

About this study

Irinotecan is a commonly used salvage chemotherapy drug for children with relapsed and refractory solid tumors. Common dose-limiting toxicities of irinotecan include abdominal pain and diarrhea. Studies have shown that patients with UGT1A16 gene mutations have a higher incidence of these side effects, thereby limiting the dosage of irinotecan. The combination of irinotecan with temozolomide and vincristine is a common salvage chemotherapy regimen for children with relapsed and refractory solid tumors. Currently, the recommended dose of irinotecan is 50mg/m², but there is still significant room for improvement in the efficacy of VIT for these children. Whether patients with wild-type UGT1A16 can further increase the dosage of irinotecan, thereby enhancing the efficacy of the VIT regimen, is the focus of our research.

This description comes directly from the study's public registry record.

Talk to the study team

Yizhuo Zhang  ·  02087342460  ·  zhangyzh@sysucc.org.cn

Juan Juan  ·  87342460  ·  wangjuan@sysucc.org.cn

Always discuss trial participation with your own doctor first.

Locations (1)

Sun Yat-sen University Cancer CenterGuangzhou, Guangdong, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06760117