Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335147
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-02-23
Brief Title:
PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon CancerSingle Arm Multicenter Phase II Clinical Study
Status:
NOT_YET_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:
Evaluate the efficacy and safety of PD1 monoclonal antibody combined with mFOLFOX6 neoadjuvant therapy for advanced resectable metastatic colon cancer with enriched pro-inflammatory pan macrophage subpopulations
Detailed Description:
In this study patients with advanced resectable metastatic colon cancer requiring neoadjuvant chemotherapy were selected and colon cancer patients enriched with TNFSF10CXCL10 panTAMs subgroup were screened and neoadjuvant chemotherapy was performed with PD-1 monoclonal antibody combined with chemotherapy To evaluate the efficacy and safety of PD-1 monoclonal antibody combined with neoadjuvant chemotherapy in the treatment of special types of colon cancer
All patients in this study were examined in the tumor microenvironment before treatment and only patients enriched with TNFSF10CXCL10 panTAMs subgroup were enrolled in the study Due to the long detection time the patient received mFOLFOX6 chemotherapy for one week in the first cycle If the test results meet the enriched proinflammatory panmacrophage subpopulation patients can eventually be enrolled and receive PD-1 monoclonal antibody Serplulimab Srulimab combined with mFOLFOX6 oxaliplatin fluorouracil regimen 2 weeks for 1 cycle The primary radical resection was performed after 5 cycles of neoadjuvant therapy Local treatment of liverlung metastases was performed at the same time or at different times Continue mFOLFOX6 chemotherapy for 4-6 cycles or CAPEOX regimen for 4 cycles within 1-2 months after surgery Liver and lung metastases allow local treatment in any of these treatment cycles including but not limited to radiofrequency ablation particle implantation radiation therapy and surgery At the end of postoperative adjuvant therapy NED status was achieved Then regular follow-up
All patients in this study were examined in the tumor microenvironment before treatment and only patients enriched with TNFSF10CXCL10 panTAMs subgroup were enrolled in the study Due to the long detection time the patient received mFOLFOX6 chemotherapy for one week in the first cycle If the test results meet the enriched proinflammatory panmacrophage subpopulation patients can eventually be enrolled and receive PD-1 monoclonal antibody Serplulimab Srulimab combined with mFOLFOX6 oxaliplatin fluorouracil regimen 2 weeks for 1 cycle The primary radical resection was performed after 5 cycles of neoadjuvant therapy Local treatment of liverlung metastases was performed at the same time or at different times Continue mFOLFOX6 chemotherapy for 4-6 cycles or CAPEOX regimen for 4 cycles within 1-2 months after surgery Liver and lung metastases allow local treatment in any of these treatment cycles including but not limited to radiofrequency ablation particle implantation radiation therapy and surgery At the end of postoperative adjuvant therapy NED status was achieved Then regular follow-up
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