Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347198
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-07
Brief Title:
Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
A Single-center Exploratory Clinical Study of Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
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 is a single-center exploratory clinical study to explore the efficacy and safety of Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer
Detailed Description:
This was a prospective two-arm single-center exploratory phase I study randomized 2 1 into an intervention group Fruquintinib combined with Sintilimab and inulin group and a control group Fruquintinib combined with Sintilimab group Fruquintinib 4 mgd QD po administered continuously for 2 weeks with a 1-week discontinuation Sintilimab 200 mg IV D1 administered every 3 weeks Inulin 5 gd qd po in the first week and 10 gd bid po starting in the second week Combination therapy was administered every 3 weeks as a treatment cycle Combination therapy was administered until disease progression death or intolerable toxicity
The study was divided into 3 phases a screening phase a treatment phase and a follow-up phase Tumor status was assessed using imaging methods every 6 weeks 7 days until disease progression RECIST 11 or death during patient treatment or intolerable toxicity and tumor treatment and survival status after disease progression were recorded Safety observations included changes in AE laboratory test values vital signs and electrocardiographic changes
The study was divided into 3 phases a screening phase a treatment phase and a follow-up phase Tumor status was assessed using imaging methods every 6 weeks 7 days until disease progression RECIST 11 or death during patient treatment or intolerable toxicity and tumor treatment and survival status after disease progression were recorded Safety observations included changes in AE laboratory test values vital signs and electrocardiographic changes
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