NCT06098560 Circulating Tumor DNA (ctDNA) as a Predictive Biomarker for Immunotherapy in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients
| NCT ID | NCT06098560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Geneplus-Beijing Co. Ltd. |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2023-10-30 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Xiaoyan Zhou, PhD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06098560 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06098560 currently recruiting?
Yes, NCT06098560 is actively recruiting participants. Contact the research team at xyzhou100@163.com for enrollment information.
Where is the NCT06098560 trial being conducted?
This trial is being conducted at Beijing, China, Shanghai, China.
Who is sponsoring the NCT06098560 clinical trial?
NCT06098560 is sponsored by Geneplus-Beijing Co. Ltd.. The principal investigator is Xiaoyan Zhou, PhD at Fudan University. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.