Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer - Trial NCT06300489
Access comprehensive clinical trial information for NCT06300489 through Pure Global AI's free database. This Phase 1 trial is sponsored by Zhejiang Cancer Hospital and is currently Recruiting. The study focuses on Rectal Cancer. Target enrollment is 30 participants.
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Study Focus
Sponsor & Location
Zhejiang Cancer Hospital
Timeline & Enrollment
Phase 1
Mar 03, 2024
Oct 31, 2025
Primary Outcome
DLT（dose-limiting toxicity）,MTD（maximum tolerable dose）
Summary
This study is a multicenter, open, and phase I dose increasing clinical study. Based on the
 UGT1A1 * 28 and * 6 genotypes of patients with locally advanced rectal cancer, determine the
 dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of weekly irinotecan liposomes
 in concurrent chemoradiotherapy with capecitabine, investigate the tolerance of irinotecan
 liposome combined with capecitabine in concurrent chemoradiotherapy with locally advanced
 rectal cancer, and recommend the dosage for Phase II clinical study，and explore the
 pharmacokinetic characteristics of irinotecan liposomes combined with capecitabine.At the
 same time，Preliminary observe the efficacy and safety of irinotecan liposomes combined with
 capecitabine in chemoradiotherapy.The study plans to recruit 30 patients with advanced rectal
 cancer who have not received any therapy.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06300489
Non-Device Trial