RecruitingNCT06098560

Circulating Tumor DNA (ctDNA) as a Predictive Biomarker for Immunotherapy in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients

Study on the Clinical Potential of Circulating Tumor DNA in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients Treated With Immunotherapy


Sponsor

Geneplus-Beijing Co. Ltd.

Enrollment

60 participants

Start Date

Oct 30, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

dMMR/MSI-H colorectal cancer patients are the dominant population of immunotherapy/neoadjuvant immunotherapy, but imaging evaluation of immunotherapy efficacy is insufficient. There are some cases, although no disease remission was found on imaging,pathological complete response (pCR) was confirmed after surgery. Meanwhile,previous studies have shown that dynamic changes in ctDNA can help assess immunotherapy efficacy. Therefore, we propose to conduct a multicenter, prospective, observational clinical study to explore the efficacy prediction and monitoring value of ctDNA in immunotherapy for advanced or locally advanced dMMR/MSI-H colorectal cancer.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a blood test that detects tumor DNA fragments (called circulating tumor DNA, or ctDNA) can predict how well immunotherapy works in people with advanced colorectal cancer that has a specific genetic feature called dMMR or MSI-H. This feature makes the cancer more likely to respond to immune checkpoint drugs. **You may be eligible if...** - You have advanced or locally advanced colorectal cancer with the dMMR or MSI-H genetic marker - You are receiving or are expected to receive immunotherapy (immune checkpoint inhibitor) - You are in reasonable health (ECOG performance score 0–1) with a life expectancy of at least 12 weeks **You may NOT be eligible if...** - You have another untreated cancer - You have serious medical conditions that interfere with study participation - You have an autoimmune condition that makes you unsuitable for PD-1 immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06098560


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