Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592287
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
The Combination of Adebrelimab Apatinib and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Dual Arm Open IbII Phase Clinical Study of the Combination of Adebrelimab Apatinib and Lrinotecan Liposome for Second-line Treatment of Advanced Gastric Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This study is a prospective dual arm open IbII phase clinical trial with the main objective of exploring the safety and efficacy of Adebrelimab combined with Apatinib and Lrinotecan liposome for second-line treatment of advanced gastric cancer
The study is divided into two stages The first stage is the safety introduction period which includes 6 patients Observe whether the subjects experience dose limiting toxicity DLT during the observation period If no subjects experience DLT during the observation period the study enters the next stage The dose of Lrinotecan liposome used during the safety introduction period is 80mgm2 and the DLTs observation period is 1 cycle If the patient cannot tolerate it the dose will be reduced to 60mgm2
In the second stage advanced gastric cancer subjects who have progressed to first-line treatment will be included in two cohorts those who have previously received immune checkpoint inhibitor therapy and have first-line PFSampgt7m cohort 1 and those who have received standard systemic chemotherapy cohort 2 30 subjects will be included in each population and a total of 66 subjects are planned to be enrolled
The study includes a screening period from the signing of the informed consent form by the subjects to the first treatment not exceeding 28 days a treatment period Adebrelimab combined with Apatinib and Lrinotecan liposome and a follow-up period including safety and survival follow-up
The study is divided into two stages The first stage is the safety introduction period which includes 6 patients Observe whether the subjects experience dose limiting toxicity DLT during the observation period If no subjects experience DLT during the observation period the study enters the next stage The dose of Lrinotecan liposome used during the safety introduction period is 80mgm2 and the DLTs observation period is 1 cycle If the patient cannot tolerate it the dose will be reduced to 60mgm2
In the second stage advanced gastric cancer subjects who have progressed to first-line treatment will be included in two cohorts those who have previously received immune checkpoint inhibitor therapy and have first-line PFSampgt7m cohort 1 and those who have received standard systemic chemotherapy cohort 2 30 subjects will be included in each population and a total of 66 subjects are planned to be enrolled
The study includes a screening period from the signing of the informed consent form by the subjects to the first treatment not exceeding 28 days a treatment period Adebrelimab combined with Apatinib and Lrinotecan liposome and a follow-up period including safety and survival follow-up
Detailed Description:
None
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