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NCT Number: NCT07492238

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ctDNA Detection, cfRNA Detection, Proteomics Analysis, Metabolomics Analysis

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Objective Response Rate (ORR)

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

    Proportion of patients with tumor volume reduction ≥30% and maintained for ≥4 weeks, including complete response (CR) and partial response (PR).

  2. Overall Survival (OS)

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

    Time from treatment initiation to death from any cause.

  3. Disease-Free State (NED)

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

    Absence of detectable tumor via imaging and clinical examination after treatment.

  4. ctDNA and cfRNA Dynamic Changes

    Time frame: 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.

    Longitudinal changes in ctDNA and cfRNA levels in blood samples collected at multiple time points.

Other outcomes

  1. ctDNA and cfRNA as Early Predictors

    Time frame: 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.

    Ability of ctDNA and cfRNA levels to predict treatment response and recurrence before imaging changes.

Sponsors and collaborators

Lead sponsor

Xiujuan Qu

Other

Registry information

Acronym: PMEIRR - OCCCT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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