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

Geneplus-Beijing Co. Ltd.60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Outcomes

Primary Outcomes

Correlation of ctDNA changes with pCR rate and the duration of cCR

Correlation of ctDNA changes with rate of pathological complete response or the duration of clinical complete response

Time frame: 2023/12-2025/12

Secondary Outcomes

Correlation of ctDNA changes with 2 years PFS

Correlation of ctDNA changes with 2 years of progression-free survival after recived immunotherapy