Genomic Signatures for Patients With Initially Unresectable Colorectal Liver Metastases

NCT06477718 | Completed

• 1 other identifier: FirstNanjingMU1111
• Study Type: observational
• Target: 286
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Genomic Instability; Prognostic Cancer Model

Outcome Measures

Primary Outcomes (1)

• Overall survival

  5 year overall survival

  5 year

Study Arms (2)

Successful Conversion Therapy Group (SCTG)

All cases were categorized into a successful conversion therapy 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this study, after excluding patients who could not complete the entire treatment regimen or did not meet the inclusion criteria, a total of 286 patients were initially diagnosed with colorectal cancer with synchronous liver metastasis, all with an initial treatment goal of No Evidence of Disease (NED). Preoperative conversion therapy was administered based on NGS results. Eventually, 106 patients achieved successful conversion (SCTG) and underwent resection or ablation of the primary and metastatic lesions, attaining NED status. Meanwhile, 180 patients, after first-line treatment, were confirmed by MDT to have unresectable metastases and were classified as the Failed Conversion Therapy Group (FCTG).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed paraffin-embedded (FFPE) tumor samples were procured via colonoscopic biopsies.

MeSH Terms

Conditions

Genomic Instability

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yueming Sun, Ph.D.;M.D.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Yueming Sun

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: June 27, 2024
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2023
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share