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

Xiujuan Qu

Status: Active, not recruiting

Conditions: Colorectal Cancer

Treatments: Drug: Plasma Multi - omics Detection

Study type: Interventional

Funder types: Other

Identifiers

NCT07492238

CMUFAH - CRC - PM

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Radical Treatment Group

Other group

Description:

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.

Treatment:

Drug: Plasma Multi - omics Detection

Non - Radical Treatment Group

Other group

Description:

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.

Treatment:

Drug: Plasma Multi - omics Detection