Plasma Multi - Omics Detection for Evaluating Efficacy and Recurrence Risk in Oligometastatic Colorectal Cancer Conversion Therapy

NCT07492238 | Active Not Recruiting

• 1 other identifier: CMUFAH - CRC - PM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study (PMEIRR-OCCCT) evaluates the utility of plasma multi-omics-including circulating tumor DNA (ctDNA), cell-free RNA (cfRNA), proteomics, and metabolomics-in assessing response to conversion therapy and predicting recurrence in 120 patients with oligometastatic colorectal cancer (≤5 liver and/or lung metastases). Blood samples are collected at predefined timepoints: before conversion therapy, 3-6 weeks post-therapy, within 2 months after surgery or non-radical treatment, and during 24-month follow-up. Patients are stratified into radical vs. non-radical treatment groups based on post-conversion resectability. Tumor assessments (CT/MRI and CEA/CA19-9) occur every 3-4 months. The primary endpoint is progression-free survival (PFS) stratified by MRD status (ctDNA-negative vs. ctDNA-positive). Secondary endpoints include objective response rate (ORR), overall survival (OS), and duration of no evidence of disease (NED). The study aims to identify multi-omic biomarkers for early recurrence prediction and personalized intervention.

Conditions

Colorectal Cancer

Keywords

Oligometastatic Colorectal Cancer; Plasma Multi - omics Detection; ctDNA; cfRNA; Proteomics; Metabolomics; Conversion Therapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) in MRD-Negative and MRD-Positive Groups

  The primary outcome is progression-free survival (PFS), stratified by minimal residual disease (MRD) status. PFS is defined as the time from treatment initiation to the first occurrence of tumor recurrence, disease progression, or death from any cause, whichever occurs first. Tumor assessments are performed every 3-4 months for up to 24 months using imaging (CT or MRI) and serum tumor markers (CEA and CA19-9). Blood samples are collected at predefined time points to determine MRD status via ctDNA analysis, which informs individualized treatment decisions. Differences in PFS between MRD-negative and MRD-positive groups are evaluated using the Kaplan-Meier method and log-rank test, with hazard ratios (HRs) and 95% confidence intervals (CIs) estimated using Cox proportional hazards regression.

  From treatment initiation through 24 months, with assessments at each follow-up visit every 3-4 months.

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Assessed at the first tumor evaluation visit, 8 weeks after treatment initiation.

• Overall Survival (OS)

  Monitored continuously from treatment initiation through 24 months, with survival status updated every 3-4 months.

• Disease-Free State (NED)

  Evaluated at each follow-up visit during the 24-month period.

• ctDNA and cfRNA Dynamic Changes

  Measured via NGS sequencing at predefined time points: before conversion therapy, 3-6 weeks after conversion therapy, within 2 months after surgery or non-radical treatment, and during follow-up.

Other Outcomes (1)

• ctDNA and cfRNA as Early Predictors

  Correlation between pre-treatment and post-treatment (e.g., 3-6 weeks after therapy) ctDNA/cfRNA levels and subsequent outcomes assessed at the end of the 24-month follow-up period.

Study Arms (2)

Radical Treatment Group

OTHER

Participants: Patients who undergo radical treatment, including surgical R0 resection or achieve NED through local therapy after conversion therapy. Interventions: Conversion Therapy: Administered per standard clinical practice, with blood samples collected before and 3 - 6 weeks after for ctDNA, cfRNA, proteomics, and metabolomics analysis. Surgery/Local Therapy: R0 resection or local therapy to achieve NED. Adjuvant Therapy: Given post - surgery based on clinical guidelines, with blood samples collected within 2 months post - treatment for MRD assessment. Follow - up: 2 - year follow - up with imaging (CT/MRI) and tumor marker tests every 3 - 4 months to monitor recurrence. Purpose: Evaluate the efficacy of conversion therapy and radical treatment in achieving tumor - free status and assess postoperative recurrence risk using MRD detection.

Drug: Plasma Multi - omics Detection

Non - Radical Treatment Group

OTHER

Participants: Patients who do not undergo radical resection or achieve NED after conversion therapy. Interventions: Conversion Therapy: Same as in Radical Treatment Group: Participants undergo plasma multi-omics detection (ctDNA, cfRNA, proteomics, and metabolomics) at the same time points to monitor disease progression and evaluate the effectiveness of non-radical treatment.

Drug: Plasma Multi - omics Detection

Interventions

Plasma Multi - omics Detection DRUG

Description: This study utilizes a holistic plasma multi-omics approach, integrating circulating tumor DNA (ctDNA), cell-free RNA (cfRNA), proteomics, and metabolomics to evaluate treatment response. Unlike conventional single-marker studies, this integration captures diverse biological signals-from genomic alterations to metabolic shifts-providing a superior assessment of efficacy and recurrence risk in oligometastatic CRC. All participants, regardless of their subsequent treatment path (radical or non-radical), undergo standardized blood collection at key clinical milestones: baseline, post-conversion therapy, and throughout a 2-year follow-up period. This allows for a continuous molecular "snapshot" of the disease, enabling the identification of MRD-positive patients who may require intensified intervention.

Also known as: ctDNA Detection, cfRNA Detection, Proteomics Analysis, Metabolomics Analysis

Non - Radical Treatment Group; Radical Treatment Group

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed oligometastatic colorectal cancer with ≤5 liver and/or lung metastases.
• Assessed as potentially resectable by multidisciplinary team (MDT) and planned for neoadjuvant conversion therapy.
• Age 18-75 years.
• Estimated survival ≥6 months.
• Willingness to provide blood samples and undergo long-term follow-up.
• Signed informed consent.

You may not qualify if:

• Pregnant or breastfeeding individuals.
• Uncontrolled medical conditions that could interfere with study assessments.
• Significant cardiac, neurological, or other severe comorbidities.
• History of other malignancies.

Sponsors & Collaborators

• Xiujuan Qu: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Oncology

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: March 25, 2026
• Study Start: March 20, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)