Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
- Disease/Condition
- Rectal Cancer
- Drug/Device/Intervention
- irinotecan liposomes+capecitabine
- Study type
- Interventional
- Intervention type
- drug
- Primary sponsor
- Zhejiang Cancer Hospital
- Location
- Hangzhou, China
- Phase
- Phase 1
- Start date
- Mar 03, 2024
- End date
- Oct 31, 2025
- Enrollment
- 30 participants
DLT（dose-limiting toxicity）,MTD（maximum tolerable dose）
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06300489
- Type
- Non-Device Trial
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.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.