RecruitingPhase 3NCT06686576

A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer

A Phase Ib/III, Open-Label, Randomized Study of Neoadjuvant QL1706 Versus Standard of Care in Participants With Untreated of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

363 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the efficacy of neoadjuvant QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon cancer


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether an immunotherapy drug called QL1706 (given before surgery) can help shrink colon cancer tumors in people with a specific type of colon cancer (dMMR/MSI-H) that tends to respond well to immunotherapy, with the goal of potentially making surgery easier or more curative. **You may be eligible if...** - You have been newly diagnosed with colon cancer (confirmed by biopsy) that has not been treated yet - Your cancer is stage IIB–III (locally advanced but not yet spread distantly) - Your cancer tests positive for MSI-H or dMMR (a specific molecular marker showing it is likely to respond to immunotherapy) - Your overall health is good (ECOG 0–1) - Your organ function is within acceptable levels **You may NOT be eligible if...** - You have already received any treatment for this cancer - Your cancer has spread to distant organs - You have an active autoimmune disease that required treatment in the past 2 years - You have a history of interstitial lung disease - You have an active infection requiring treatment 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

DRUGQL1706

Phase Ib/Ⅲ: QL1706 will be administered

DRUGCAPEOX/Capecitabine

Phase Ⅲ:CAPEOX/Capecitabine will be administered


Locations(1)

Affiliated Cancer Hospital of Sun Yat-sen University

Guangzhou, China

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NCT06686576


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