Colorectal CancerPMEIRR - OCCCTNCT07492238
Plasma Multi - Omics Detection for Evaluating Efficacy and Recurrence Risk in Oligometastatic Colorectal Cancer Conversion Therapy
A study testing Plasma Multi - omics Detection in people with Colorectal Cancer, run by Xiujuan Qu at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Plasma Multi - omics Detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or breastfeeding individuals.
- Uncontrolled medical conditions that could interfere with study assessments.
- Significant cardiac, neurological, or other severe comorbidities.
- History of other malignancies.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
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
- Being tested
- Plasma Multi - omics Detection
- Keywords
- Oligometastatic Colorectal Cancer, Plasma Multi - omics Detection, ctDNA, cfRNA, Proteomics, Metabolomics, Conversion Therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma Multi - omics DetectionDrug
Also called ctDNA Detection, cfRNA Detection, Proteomics Analysis, Metabolomics Analysis
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Plasma Multi - omics Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From treatment initiation through 24 months, with assessments at each follow-up visit every 3-4 months.
Secondary outcomes (4)
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).
Measured: Assessed at the first tumor evaluation visit, 8 weeks after treatment initiation.
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Measured: 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.
Measured: 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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start20 Mar 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiujuan Qu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiujuan Qu, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492238
- Sponsor's protocol ID
- CMUFAH - CRC - PM
- Acronym
- PMEIRR - OCCCT
- Status last verified
- Mar 2026
- First submitted
- 8 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Multi - Omics Detection for Evaluating Efficacy and Recurrence Risk in Oligometastatic Colorectal Cancer Conversion Therapy
- ClinicalTrials.gov ID
- NCT07492238
- Acronym / sponsor ID
- PMEIRR - OCCCT / CMUFAH - CRC - PM
- Conditions
- Colorectal Cancer
- Keywords
- Oligometastatic Colorectal Cancer, Plasma Multi - omics Detection, ctDNA, cfRNA, Proteomics, Metabolomics, Conversion Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xiujuan QuUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical Treatment Group | Other | Drug: Plasma Multi - omics DetectionParticipants: 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. |
| Non - Radical Treatment Group | Other | Drug: Plasma Multi - omics DetectionParticipants: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding individuals.
- Uncontrolled medical conditions that could interfere with study assessments.
- Significant cardiac, neurological, or other severe comorbidities.
- History of other malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma Multi - omics DetectionAlso: ctDNA Detection, cfRNA Detection, Proteomics Analysis, Metabolomics AnalysisDescription: 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. | Drug | Non - Radical Treatment Group, Radical Treatment Group |
Primary outcome
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.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Assessed at the first tumor evaluation visit, 8 weeks after treatment initiation.
Overall Survival (OS)
Time frame: Monitored continuously from treatment initiation through 24 months, with survival status updated every 3-4 months.
Disease-Free State (NED)
Time frame: Evaluated at each follow-up visit during the 24-month period.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma Multi - omics Detection in people with Colorectal Cancer, run by Xiujuan Qu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.