RecruitingPhase 2NCT05815290

Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer

A Phase II Trial of Cadonilimab in Locally Advanced Stage II/III MSI-H/dMMR Colorectal Cancer


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

50 participants

Start Date

Mar 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a two-arm phase II clinical study to evaluate the efficacy and safety of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced colorectal cancer as the regimen of neoadjuvant treatment. Eligible patients will receive Cadonilimab monotherapy for eight cycles before surgery and part of patients may exempt from surgery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether adding cadonilimab (an immunotherapy drug) to standard treatment can improve outcomes for people with locally advanced colorectal cancer that has a specific molecular marker called MSI-H or dMMR — meaning the cancer cells have a defect in their DNA repair system, which can make them respond better to immunotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with colon or rectal cancer that is locally advanced (spread to nearby lymph nodes or through the bowel wall) - Your tumor has been confirmed as MSI-H or dMMR by lab tests - You have not received any prior treatment for this cancer - You are in good health (ECOG 0–1) **You may NOT be eligible if...** - You have already received treatment for this cancer - Your blood counts, liver, or kidney function are not within acceptable ranges - You have active autoimmune disease or are on long-term steroids - You are pregnant or breastfeeding 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

DRUGCadonilimab

Cadonilimab 10mg/kg iv on day 1 for every 21 days with a total of 8 cycles


Locations(1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT05815290


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