Exploring ctDNA for Immunotherapy in Advanced Colorectal Cancer
Official title: Study on the Clinical Potential of Circulating Tumor DNA in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients Treated With Immunotherapy
Run by Geneplus-Beijing Co. Ltd. · NCT06098560 · Data updated 2026-11-12
This study is testing if tracking changes in tumor DNA can help doctors see how well immunotherapy works for people with advanced colorectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Geneplus-Beijing Co. Ltd. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | October 30, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT06098560 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with advanced or locally advanced dMMR/MSI-H colorectal cancer who are expected to receive immune checkpoint inhibitor therapy.
✕Probably not a fit
Patients with other uncured malignancies or serious systemic diseases that impair their ability to complete the study may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the efficacy of immunotherapy in patients with advanced or locally advanced dMMR/MSI-H colorectal cancer by monitoring changes in circulating tumor DNA (ctDNA). It seeks to determine how ctDNA can predict and assess the effectiveness of immune checkpoint inhibitors, especially in cases where imaging does not show disease remission. The study will be multicenter and prospective, involving patients who are expected to receive or are currently receiving immunotherapy. By focusing on ctDNA dynamics, the study hopes to provide insights into treatment responses that traditional imaging may miss.
Why it matters
Potential benefit: If successful, this study could improve the monitoring and prediction of treatment responses in colorectal cancer patients undergoing immunotherapy.
How similar studies have gone: Previous studies have indicated that ctDNA can be a valuable biomarker for assessing immunotherapy efficacy, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- advanced or locally advanced dMMR/MSI-H colorectal cancer Expected to receive/be receiving immune checkpoint inhibitor therapy ECOG performance score is 0-1, life expectancy ≥12 weeks Exclusion Criteria: \- The presence of other uncured malignancies Patients with one or more serious concomitant systemic diseases that, in the investigator's opinion, impair the patient's ability to complete the study Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy
Where it's running
-
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China Recruiting -
Fudan University Shanghai Cancer Center
Shanghai, China Recruiting
Study contacts
- Principal investigator: Xiaoyan Zhou, PhD — Fudan University
- Study coordinator: Xiaoyan Zhou, PhD
- Email: xyzhou100@163.com
- Phone: +86 13524324387
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.