Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512428
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Multicenter Phase II Clinical Trial to Explore the Safety and Efficacy of Simmitinib Plus Irinotecan Liposome in Patients With Advanced Esophageal Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and efficacy of simmitinib plus irinotecan liposome in the treatment of advanced esophageal squamous cell carcinoma and to evaluate the PK of the drug and the correlation between biomarkers and clinical efficacy of simmitinib plus irinotecan liposome
Detailed Description:
The experiment was divided into two stages The first stage is dose escalation stage Rapid titration and 33 dose escalation design were used to observe DLT of simmitinib plus irinotecan liposome and MTD was determined The second stage is a randomized controlled study After RP2D was determined in the first stage participants were randomly assigned to 3 groups in a 111 ratio including simmitinib plus irinotecan liposome irinotecan liposome and irinotecan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None