See if ctDNA MRD testing can guide how long to keep immunotherapy in metastatic MSI-H/dMMR colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study looks at using circulating tumor DNA to measure molecular residual disease in patients with metastatic MSI-H/dMMR colorectal cancer who are receiving immunotherapy. After one year of treatment, patients with two consecutive negative MRD results will be randomized to continue therapy or stop and be observed. The goal is to determine if MRD can guide treatment duration to maintain benefit while reducing exposure and adverse events. Eligibility requires confirmed dMMR/MSI-H status, stage IV disease, and no prior immunotherapy for the current cancer. The study is led by Sun Yat-sen University at their cancer center in Guangzhou.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntary participation in the study and provision of written informed consent.
2. Age ≥18 years at the time of signing informed consent.
3. Histologically confirmed colorectal adenocarcinoma with mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) status.
4. Clinically confirmed stage IV disease.
5. No prior immunotherapy for the current colorectal cancer.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
7. Availability of adequate pretreatment tumor tissue and peripheral blood samples for whole-exome sequencing (WES) and personalized circulating tumor DNA (ctDNA)/MRD analysis.
8. Life expectancy \>12 months.
9. Willing and able to comply with the study procedures and scheduled follow-up.

Exclusion Criteria:

1. Presence of another malignancy.
2. Prior immunotherapy for the current stage IV colorectal cancer.
3. Organ transplantation within 3 months before enrollment.
4. History of blood transfusion within 3 months before enrollment.
5. Active, known, or suspected autoimmune disease, or evidence of active or chronic infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
6. Pregnancy or breastfeeding.
7. Presence of a serious concurrent disease that, in the investigator's judgment, may substantially affect life expectancy or study participation.
8. Failure to provide written informed consent.
9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Peirong Ding, M.D. — Sun Yat-Sen University Cancer Center
• Study coordinator: Binyi Xiao, M.D
• Email: xiaoby@sysucc.org.cn
• Phone: +86-15800004780

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.