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Trial Title:
A Biomarker Study for Immunotherapy in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients
NCT ID:
NCT06098560
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Colorectal cancer patients with MSI-H/dMMR who are expected to receive / receiving
immunotherapy
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoyan Zhou
Phone:
+86 13524324387
Email:
xyzhou100@163.com
Start date:
October 30, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Geneplus-Beijing Co. Ltd.
Agency class:
Industry
Source:
Geneplus-Beijing Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06098560
