NCT06477991

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.

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(WINDOW): A Single-center, Open-label, Prospective, Phase II Clinical Trial.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Yunnan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-10-30
• Primary completion: 2025-10-30
• Completion: 2026-10-30
• First posted: 2024-06-27
• Last updated: 2024-06-27

Locations

1 site across 1 country: China