Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300489
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-03
Brief Title:
Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
Genotype-driven Phase I Study of Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 studyand explore the pharmacokinetic characteristics of irinotecan liposomes combined with capecitabineAt the same timePreliminary observe the efficacy and safety of irinotecan liposomes combined with capecitabine in chemoradiotherapyThe study plans to recruit 30 patients with advanced rectal cancer who have not received any therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None