RecruitingPhase 2NCT06321081

ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC

ICE Study: a Clinical Study of the Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC


Sponsor

Beijing Hospital

Enrollment

60 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called the ICE Study — tests a combination of three drugs (irinotecan, cetuximab, and envafolimab) as a re-challenge treatment for patients with metastatic colorectal cancer (cancer that has spread) who previously responded to cetuximab or irinotecan but whose cancer later progressed. **You may be eligible if...** - You are 18 years or older - You have been confirmed to have metastatic colorectal adenocarcinoma - Your cancer has specific gene profiles (RAS and BRAF wild-type) confirmed by liquid biopsy - You previously had a complete or partial response to a first-line treatment including cetuximab or irinotecan - It has been more than 2 months since your last cetuximab dose - You have measurable cancer and a good performance status (ECOG 0 or 1) **You may NOT be eligible if...** - You have not previously responded to cetuximab or irinotecan - You have active autoimmune disease - You are pregnant or breastfeeding - You have serious medical conditions affecting your ability to receive 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

DRUGirinotecan, cetuximab, envafolimab

rechallenge treatment


Locations(1)

Beijing Hospital

Beijing, Beijing Municipality, China

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NCT06321081


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