Genomic Signatures for Patients With Initially Unresectable Colorectal Liver Metastases

NCT ID: NCT06477718

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 286 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2023-12-01

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.

Conditions

Genomic Instability; Prognostic Cancer Model

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Successful Conversion Therapy Group (SCTG)

All cases were categorized into a successful conversion therapy group

No interventions assigned to this group

Failed Conversion Therapy Group (FCTG)

if they achieved no evidence of disease (NED) status through surgery after conversion therapy, and a failed conversion therapy group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

At diagnosis, all patients met the criteria for preoperative conversion therapy, with a Cancer Recurrence Score (CRS) of ≥3

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yueming Sun

Dr. Yueming Sun

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yueming Sun, Ph.D.;M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Other Identifiers

FirstNanjingMU1111

Identifier Type: -

Identifier Source: org_study_id