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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorGeneplus-Beijing Co. Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Colorectal cancer patients with MSI-H/dMMR who are expected to receive / receiving immunotherapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

1

Correlation of ctDNA changes with 2 years PFS

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

Time frame
2023/12-2025/12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.