Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05753163
Status:
RECRUITING
Last Update Posted:
2023-03-03
First Post:
2023-02-21
Brief Title:
Hepatic Arterial Infusion Chemotherapy Combined With Sintilimab and Regorafenib as Adjuvant Therapy for Colorectal Liver Metastasis Patients With a High Risk of Recurrent a Single-arm Phase II Study
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Hepatic Arterial Infusion Chemotherapy Combined With Sintilimab and Regorafenib as Adjuvant Therapy for Colorectal Liver Metastasis Patients With a High Risk of Recurrent a Single-arm Phase II Study
Status:
RECRUITING
Status Verified Date:
2023-03
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:
Pts with histologically confirmed CRLM and whose CRS 2 were enrolled into this single-arm phase II study The critical enrollment criteria were that Subjects had completely resected Primary lesion and liver metastases and had no evidence of extrahepatic disease After hepatectomy HAIC FOLFOX oxaliplatin 85mgm2 5- fluorouracil 2500mgm2 calcium folinate 400mgm2 was given every 4-6 weeks for 2-4 cycles depending on pts health status in combination with Sintilimab 200mg iv d1 and regorafenib 80mg po d1-21 every 3 weeks for up to 6 months The primary endpoint was 1-year recurrence-free survival RFS and secondary endpoints included RFS overall survival OS safety and health-related quality of life
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