Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563947
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Single Arm Clinical Trial Gut Microbiota and HCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Study to Evaluate the Effectiveness of Oral Enterobacterial Capsules in Patients With Intermediate and Advanced HCC Who Have Progressed After Immune Checkpoint Inhibitor Combination With Anti-Angiogenesis Targeted Agents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced HCC who have progressed after treating with immune checkpoint inhibitors in combination with anti-angiogenesis targeted agents
Detailed Description:
This is a prospective single-center single-arm clinical study For those who meet the enrollment conditions the original regimen of immune checkpoint inhibitors combined with anti-angiogenic targeted drugs will remain unchanged after enrollmentOn this basis the study subjects started oral enterobacterial capsules to see whther enterobacterial capsules could improve the efficacy of patients receiving the above treatment regimens
Oral administration of intestinal bacteria capsules 6 capsulesday after observing no adverse reactions oral administration for 10 consecutive days 6 capsulesday from the second day to the tenth day and then discontinued to the next course of treatment
Total course of treatment a total of 4 courses of oral intestinal bacteria capsules each course of oral administration for 10 days and a course of 21 days A course of TKI combined with immune checkpoint inhibitors treatment is 21 days until the disease progresses or intolerable toxicity and side effects appear
Observe the metrics Primary Clinical Endpoint - Progression-Free Survival PFS Secondary Clinical Endpoints - Overall Growth Phase OS Objective Response Rate ORR Duration of Response DOR and Disease Control Rate DCR The new RECIST11 criteria were used for the efficacy evaluation system the CTCAE50 grading system was used for the evaluation of common adverse reactions during treatment and other indicators included imaging including conventional biochemical indexes such as CT and ultrasound as well as quality of life scores
Oral administration of intestinal bacteria capsules 6 capsulesday after observing no adverse reactions oral administration for 10 consecutive days 6 capsulesday from the second day to the tenth day and then discontinued to the next course of treatment
Total course of treatment a total of 4 courses of oral intestinal bacteria capsules each course of oral administration for 10 days and a course of 21 days A course of TKI combined with immune checkpoint inhibitors treatment is 21 days until the disease progresses or intolerable toxicity and side effects appear
Observe the metrics Primary Clinical Endpoint - Progression-Free Survival PFS Secondary Clinical Endpoints - Overall Growth Phase OS Objective Response Rate ORR Duration of Response DOR and Disease Control Rate DCR The new RECIST11 criteria were used for the efficacy evaluation system the CTCAE50 grading system was used for the evaluation of common adverse reactions during treatment and other indicators included imaging including conventional biochemical indexes such as CT and ultrasound as well as quality of life scores
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