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

NCT06098560 · tracked via the Priya Life Science China tracker

Sponsor

Geneplus-Beijing Co. Ltd.

Phase

Observational

Started

2023-10-30

Last updated

2026-06-30

Condition(s) studied

Colorectal Cancer

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Correlation of ctDNA changes with pCR rate and the duration of cCR — 2023/12-2025/12
Correlation of ctDNA changes with rate of pathological complete response or the duration of clinical complete response

Trial sites (2)

Facility	City	Region	Status
Peking Union Medical College Hospital	Beijing	Beijing Municipality	Recruiting
Fudan University Shanghai Cancer Center	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06098560 on ClinicalTrials.gov ↗ ← All trials in China