Exploring ctDNA for Immunotherapy in Advanced Colorectal Cancer
Study on the Clinical Potential of Circulating Tumor DNA in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients Treated With Immunotherapy
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Geneplus-Beijing Co. Ltd. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06098560 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have indicated that ctDNA can be a valuable biomarker for assessing immunotherapy efficacy, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.