Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 8:21 PM
Study NCT ID:
NCT06643793
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2024-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC
Sponsor:
Affiliated Hospital of Nantong University
Organization:
Study Overview
Official Title:
Evaluation of Irinotecan Liposome (II) Combined With 5-fluorouracil, Leucovorin, and Bevacizumab for Second-line/Third-line Treatment of Metastatic Colorectal Cancer (mCRC): a Prospective and Exploratory Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
To observe and evaluate the efficacy and safety of irinotecan liposome (II) combined with 5-fluorouracil(5-FU), calcium leucovorin(LV), and bevacizumab in the treatment of metastatic colorectal cancer.
Detailed Description:
Subjects enter the screening period after being fully informed and signing an informed consent form. The screening period for the study is 28 days. After completing the screening inspection and evaluation, the selected subjects receive irinotecan liposome (II) combined with 5-FU/LV and bevacizumab treatment, a total of 4 anti-tumor treatment cycles were observed. After the 4 cycles of treatment, the next step of treatment was jointly decided after the evaluation of the researcher and the consideration of the patient's personal treatment wishes.
Study Oversight
Has Oversight DMC:
False
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?: