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The Efficacy of Watch and Wait Strategy or Surgery After Neoadjuvant Immunotherapy for Locally Advanced Colorectal Cancer With dMMR/MSI-H Guided by MRD Dynamic Monitoring: A Single-center, Open-label, Prospective, Phase II Clinical Trial.

NCT06477991 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2024-06-27

No results posted yet for this study

Summary

This study is a single arm, single center, phase II, prospective clinical study aimed at exploring the effectiveness and safety of watch and wait strategy guided by dynamic minimal disease residual (MRD) monitoring to achieve clinical complete response after neoadjuvant immunotherapy for locally advanced colorectal cancer with deficient mismatch repair/ microsatellite instability-high (dMMR/MSI-H).

Conditions

  • Clinical Complete Response Rate With Negative MRD

Interventions

DRUG

Tireilizumab（PD-1 inhibitor）

Neoadjuvant immunotherapy phase : 1. Pharmaceuticals: Tireilizumab: 200mg, intravenous infusion, Q3W, at least 4 cycles, the number of specific neoadjuvant immunotherapy cycles was determined according to the results of MRD dynamic monitoring. 2. MRD dynamic monitoring time node: dynamic monitoring at the initial diagnosis and after the fourth cycle of neoadjuvant immunotherapy. Blood monitoring points were 1-2 weeks after immunotherapy. If the two consecutive MRDs were negative, the watch and wait strategy was adopted. If the MRD was still positive after 8 cycles of neoadjuvant immunotherapy, surgical treatment was performed.

Sponsors & Collaborators

  • Yunnan Cancer Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2025-10-30
Completion
2026-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06477991 on ClinicalTrials.gov