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

Study on the Clinical Potential of Circulating Tumor DNA in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients Treated With Immunotherapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06098560

Enrollment

Registered

2023-10-24

Start date

2023-10-30

Completion date

2026-12-01

Last updated

2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 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

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
Correlation of ctDNA changes with 2 years PFS	2023/12-2025/12	Correlation of ctDNA changes with 2 years of progression-free survival after recived immunotherapy

Countries

China

Contacts

CONTACTXiaoyan Zhou, PhD

xyzhou100@163.com+86 13524324387

CONTACTJunjie Peng, PhD

pengjj@shca.org.cn+86 13917373312

PRINCIPAL_INVESTIGATORXiaoyan Zhou, PhD

Fudan University

Outcome results