Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463548
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-03
Brief Title:
Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma
Sponsor:
Yunpeng Liu
Organization:
China Medical University China
Study Overview
Official Title:
Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine and Lenvatinib for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma
Detailed Description:
To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma
Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle
Drug Irinotecan hydrochloride liposome injection 70mgm2 will be administered by intravenous infusion on day 1 in a 2-week treatment cycle
Drug Capecitabine 850 mgm2 will be administered orally in a 2-week treatment cycle twice a day from day 1 to day 10 of each cycle
Drug Lenvatinib 8 mg will be administered orally in a 2-week treatment cycle once a day from day 1 to day 14 of each cycle
Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle
Drug Irinotecan hydrochloride liposome injection 70mgm2 will be administered by intravenous infusion on day 1 in a 2-week treatment cycle
Drug Capecitabine 850 mgm2 will be administered orally in a 2-week treatment cycle twice a day from day 1 to day 10 of each cycle
Drug Lenvatinib 8 mg will be administered orally in a 2-week treatment cycle once a day from day 1 to day 14 of each cycle
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