A Biomarker Study for Immunotherapy in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT06098560
• Lead Sponsor: Geneplus-Beijing Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Study Start: 2023-10-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China