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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Plasma Multi - omics Detection

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Affiliated Hospital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Radical Treatment Group; 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; 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.; Other Names: ctDNA Detection; cfRNA Detection; Proteomics Analysis; Metabolomics Analysis
Other: Non - Radical Treatment Group; 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; 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.; Other Names: ctDNA Detection; cfRNA Detection; Proteomics Analysis; Metabolomics Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Proportion of patients with tumor volume reduction ≥30% and maintained for ≥4 weeks, including complete response (CR) and partial response (PR).	Assessed at the first tumor evaluation visit, 8 weeks after treatment initiation.
Overall Survival (OS)	Time from treatment initiation to death from any cause.	Monitored continuously from treatment initiation through 24 months, with survival status updated every 3-4 months.
Disease-Free State (NED)	Absence of detectable tumor via imaging and clinical examination after treatment.	Evaluated at each follow-up visit during the 24-month period.
ctDNA and cfRNA Dynamic Changes	Longitudinal changes in ctDNA and cfRNA levels in blood samples collected at multiple time points.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA and cfRNA as Early Predictors	Ability of ctDNA and cfRNA levels to predict treatment response and recurrence before imaging changes.	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.

Collaborators and Investigators

• Sponsor: Xiujuan Qu

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Metabolomics; Proteomics; ctDNA; Conversion Therapy; cfRNA; Oligometastatic Colorectal Cancer; Plasma Multi - omics Detection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CMUFAH - CRC - PM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study involves sensitive patient information and complex multi - omics data. Sharing IPD could risk patient privacy and requires substantial resources to manage properly. However, we're open to future collaborations to potentially share findings in a controlled manner.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No