Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004713
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-08-16
Brief Title:
Registry Study in MSIdMMR Solid Tumors
Sponsor:
Peking University Cancer Hospital Institute
Organization:
Peking University Cancer Hospital Institute
Study Overview
Official Title:
Multi-center Non-interventional Prospective Registry Study on the Treatment of Solid Tumors With Mismatch Repair Deficiency or Microsatellite Instability
Status:
RECRUITING
Status Verified Date:
2023-07
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 study is a multi-center non-interventional prospective clinical observational study aiming to evaluate the effectiveness and safety of subsequent treatment in dMMRMSI solid tumor patients who have never received ICIs under real-world conditions Particular attention is paid to the efficacy in populations where treatment plans are adjusted based on ctDNA and potential predictive or prognostic biomarkers are explored
Detailed Description:
This study plans to enroll patients in the following four cohorts
Cohort A Initially only receiving PD1PDL1 monotherapy
Cohort B Initially receiving simultaneous blockade of PD1PDL1 and CTLA4
Cohort C Initially receiving PD1PDL1 monotherapy combined with chemotherapy or targeted therapy
Cohort D Initially not using ICIs receiving other standard treatments for this tumor type
To explore the role of ctDNA testing in therapeutic decision-making patients with the first evaluation of SD in cohort A are divided into two groups ctDNA testingintervention group Group A1 and ctDNA testingnon-intervention group Group A2 In group A1 if there is no early response to ctDNA the researchers and the patient will decide to add CTLA4 antibody or other potentially effective treatments after thorough communication If there is an early response to ctDNA then continue with PD1PDL1 monoclonal antibody treatment Patients in group A2 undergo ctDNA testing but still continue with PD1PDL1 monoclonal antibody treatment according to the RECIST v11 standard when the first evaluation of SD is made Meanwhile explore the role of 1-year ctDNA-MRD in guiding treatment in patients with long-term tumor control and explore the guiding role of re-biopsy of tumor tissue or ctDNA testing in helping making treatment regimen after progression on ICIs
Number of Subjects
This study will recruit patients nationwide for data collection over a period of 3 years The plan is to enroll 100 cases in Cohort A including 25 cases in Group A1 and 25 cases in Group A2 30 cases in Cohort B 30 cases in Cohort C and 30 cases in Cohort D
Cohort A Initially only receiving PD1PDL1 monotherapy
Cohort B Initially receiving simultaneous blockade of PD1PDL1 and CTLA4
Cohort C Initially receiving PD1PDL1 monotherapy combined with chemotherapy or targeted therapy
Cohort D Initially not using ICIs receiving other standard treatments for this tumor type
To explore the role of ctDNA testing in therapeutic decision-making patients with the first evaluation of SD in cohort A are divided into two groups ctDNA testingintervention group Group A1 and ctDNA testingnon-intervention group Group A2 In group A1 if there is no early response to ctDNA the researchers and the patient will decide to add CTLA4 antibody or other potentially effective treatments after thorough communication If there is an early response to ctDNA then continue with PD1PDL1 monoclonal antibody treatment Patients in group A2 undergo ctDNA testing but still continue with PD1PDL1 monoclonal antibody treatment according to the RECIST v11 standard when the first evaluation of SD is made Meanwhile explore the role of 1-year ctDNA-MRD in guiding treatment in patients with long-term tumor control and explore the guiding role of re-biopsy of tumor tissue or ctDNA testing in helping making treatment regimen after progression on ICIs
Number of Subjects
This study will recruit patients nationwide for data collection over a period of 3 years The plan is to enroll 100 cases in Cohort A including 25 cases in Group A1 and 25 cases in Group A2 30 cases in Cohort B 30 cases in Cohort C and 30 cases in Cohort D
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