Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This study aims to evaluate whether plasma molecular residual disease (MRD), assessed using circulating tumor DNA (ctDNA), can help optimize the duration of immunotherapy in patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer. Patients with MSI-H/dMMR metastatic colorectal cancer can achieve durable responses to immune checkpoint inhibitors, but the optimal duration of treatment remains uncertain. Prolonged immunotherapy may increase treatment burden and the risk of immune-related adverse events. ctDNA-based MRD testing may provide a sensitive method for detecting residual tumor burden and identifying patients who may be able to safely stop treatment. In this study, patients receiving immunotherapy will undergo serial plasma MRD testing. After completing 1 year of immunotherapy, patients with two consecutive negative MRD results will be randomly assigned to either continue immunotherapy or stop treatment and enter observation. Patients will then be followed every 3 months for 2 years with MRD testing and routine clinical assessments, including imaging and laboratory examinations. The study will compare clinical outcomes between the two groups and evaluate whether serial plasma MRD monitoring can support a more individualized approach to the duration of immunotherapy in MSI-H/dMMR metastatic colorectal cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dobrowolna zgoda na udział w badaniu i podpisanie dokumentu zgody
- •Wiek co najmniej 18 lat
- •Potwierdzony histologicznie rak gruczołowy jelita grubego z defektem naprawy DNA (dMMR) lub wysoką niestabilnością mikrosatelitów (MSI-H)
- •Potwierdzony zaawansowany stadium choroby (etap IV)
- •Bez wcześniejszego leczenia immunoterapią
- •Dobry stan ogólny (ECOG 0-1)
- •Dostępne próbki tkanki nowotworu i krwi do badań genetycznych
- •Spodziewana długość życia powyżej 12 miesięcy
✗ Disqualifies
- •Obecność innego nowotworu
- •Wcześniejsza immunoterapia w tym zaawansowanym stadium raka
- •Przeszczep narządu w ciągu ostatnich 3 miesięcy
- •Transfuzja krwi w ciągu ostatnich 3 miesięcy
- •Aktywna choroba autoimmunologiczna lub zakażenie wirusem B, C lub HIV
- •Ciąża lub karmienie piersią
- •Poważne choroby współistniejące mogące wpłynąć na życie
- •Brak możliwości wypełnienia procedur badania
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 20, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, China
Trial contact
Binyi Xiao, M.D
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/21/2026.
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