RecruitingNCT06477991

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.


Sponsor

Yunnan Cancer Hospital

Enrollment

22 participants

Start Date

Oct 30, 2023

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether some patients with locally advanced colorectal cancer who achieve a complete response (no detectable cancer) after immunotherapy can safely skip surgery — a "watch and wait" approach — guided by blood tests that detect tiny amounts of cancer DNA. This applies only to tumors with a specific DNA repair defect (called dMMR or MSI-H). **You may be eligible if...** - You have been confirmed to have colorectal cancer (specifically adenocarcinoma) - Your tumor has the dMMR or MSI-H marker (a specific molecular feature detectable by biopsy) - Your cancer is locally advanced (stage II–III) with no distant spread - You have no signs of bowel obstruction (or it has been resolved) **You may NOT be eligible if...** - Your tumor does not have the dMMR/MSI-H marker - Your cancer has spread to other organs or distant lymph nodes - You have had prior treatment for colorectal cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTireilizumab(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.


Locations(1)

Yunnan Cancer Hospital

Kunming, Yunnan, China

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NCT06477991