Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-01 @ 5:55 PM
Study NCT ID:
NCT06477718
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genomic Signatures for Patients With Initially Unresectable Colorectal Liver Metastases
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
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 and/or 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 (i.e., 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 FOLFOX/FOLFIRI 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 (i.e., 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 FOLFOX/FOLFIRI 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:
False
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?: