Clinical trial · Interventional
Plasma Multi - Omics Detection for Evaluating Efficacy and Recurrence Risk in Oligometastatic Colorectal Cancer Conversion Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma Multi - omics Detection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Radical Treatment 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.
- interventionNames
- Drug: Plasma Multi - omics Detection
- type
- OTHER
- label
- Non - Radical Treatment 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available