Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477718
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-06-22
Brief Title:
Genomic Signatures for Patients With Initially Unresectable Colorectal Liver Metastases
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Diverse Genomic Signatures Predict Resection Conversion and Survival Outcomes in Patients With Initially Unresectable Colorectal Liver Metastases
Status:
COMPLETED
Status Verified Date:
2024-06
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:
A retrospective cohort of 286 patients with synchronous CRLM underwent conversion therapies based on next-generation sequencing NGS results All cases were categorized into a successful conversion therapy group SCTG if they achieved no evidence of disease NED status through surgery after conversion therapy and a failed conversion therapy group FCTG otherwise Clinical risk factors and genomic mutations were analyzed for association with conversion therapy outcomes and survival
Detailed Description:
All procedures involving human participants in this study adhered to ethical standards set by institutional andor national research committees as well as the 1964 Helsinki Declaration and its later amendments or similar ethical standards This cohort study has been reported in line with the STROCSS criteria
This study enrolled 286 patients initially diagnosed with colorectal cancer CRC concomitant with synchronous liver metastases All patients received comprehensive treatment and follow-up at the Department of Colorectal Surgery First Affiliated Hospital of Nanjing Medical University between 2016 and 2018 At diagnosis all patients met the criteria for preoperative conversion therapy with a Cancer Recurrence Score CRS of 3 Patients were excluded if they i could not tolerate a full course of systemic therapy ii had a history of other malignancies iii had previously undergone cancer treatment or iv Patients who were not rendered disease-free at time of hepatic resection ie primary intact unresected extrahepatic disease or gross R2 residual hepatic disease were excluded Next-generation sequencing NGS was conducted on biopsy tissues obtained via colonoscopy prior to treatment initiation and conversion therapies were subsequently administered Systemic treatment regimens based on NGS results included FOLFOXFOLFIRI or FOLFOXIRI combined with anti-EGFR or anti-VEGF agents excluding those who received Selective Internal Radiation Therapy SIRT or Stereotactic Body Radiation Therapy SBRT All patients were microsatellite stable MSS and did not receive any immune checkpoint therapies such as PD-1 inhibitors Patients with locally advanced rectal cancer received additional neoadjuvant radiotherapy to the rectal area Treatment response was assessed every two cycles and resectability of the primary tumor and metastases were evaluated post-treatment using abdominal contrast-enhanced CT and MRI
This study enrolled 286 patients initially diagnosed with colorectal cancer CRC concomitant with synchronous liver metastases All patients received comprehensive treatment and follow-up at the Department of Colorectal Surgery First Affiliated Hospital of Nanjing Medical University between 2016 and 2018 At diagnosis all patients met the criteria for preoperative conversion therapy with a Cancer Recurrence Score CRS of 3 Patients were excluded if they i could not tolerate a full course of systemic therapy ii had a history of other malignancies iii had previously undergone cancer treatment or iv Patients who were not rendered disease-free at time of hepatic resection ie primary intact unresected extrahepatic disease or gross R2 residual hepatic disease were excluded Next-generation sequencing NGS was conducted on biopsy tissues obtained via colonoscopy prior to treatment initiation and conversion therapies were subsequently administered Systemic treatment regimens based on NGS results included FOLFOXFOLFIRI or FOLFOXIRI combined with anti-EGFR or anti-VEGF agents excluding those who received Selective Internal Radiation Therapy SIRT or Stereotactic Body Radiation Therapy SBRT All patients were microsatellite stable MSS and did not receive any immune checkpoint therapies such as PD-1 inhibitors Patients with locally advanced rectal cancer received additional neoadjuvant radiotherapy to the rectal area Treatment response was assessed every two cycles and resectability of the primary tumor and metastases were evaluated post-treatment using abdominal contrast-enhanced CT and MRI
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