Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563934
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Gut Microbiota in Liver Cancer Treated With TKIs In Combination With ICIs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial Evaluating the Effects of Oral Enterobacterial Capsules in Liver Cancer Patients Treated With Tyrosine Kinase Inhibitors TKIs in Combination With Immune Checkpoint Inhibitors ICIs
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 additional efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced liver cancer and treated with tyrosine kinase inhibitors TKIs combined with immunotherapy
Detailed Description:
This is a prospective single-center randomized double-blind controlled trial The clinical study is divided into 2 groups
Group 1 Patients in the control group were given lenvatinib 8mg 60 kg body weight or 12 mg 60 kg body weight orally once a day combined with PD-1 monoclonal antibody 200mg intravenously once every 3 weeks until disease progression intolerable toxicity or death and patients in the control group were given intestinal bacteria capsules placebo
Group 2 Patients in the study group were given lenvatinib 8 mg 60 kg body weight or 12 mg 60 kg body weight orally once a day in combination with PD-1 monoclonal antibody 200 mg intravenously every 3 weeks until disease progression intolerable toxicity or death and patients in this study group were given intestinal bacteria capsules
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
Group 1 Patients in the control group were given lenvatinib 8mg 60 kg body weight or 12 mg 60 kg body weight orally once a day combined with PD-1 monoclonal antibody 200mg intravenously once every 3 weeks until disease progression intolerable toxicity or death and patients in the control group were given intestinal bacteria capsules placebo
Group 2 Patients in the study group were given lenvatinib 8 mg 60 kg body weight or 12 mg 60 kg body weight orally once a day in combination with PD-1 monoclonal antibody 200 mg intravenously every 3 weeks until disease progression intolerable toxicity or death and patients in this study group were given intestinal bacteria capsules
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