RecruitingPhase 3NCT06951503

AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer

A Randomized, Controlled, Multicenter Phase III Clinical Study of AK112 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy in First-line Metastatic Colorectal Cancer


Sponsor

Akeso

Enrollment

560 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an experimental immunotherapy drug (AK112, which targets both PD-1 and VEGF) with standard chemotherapy as a first-line treatment for patients with metastatic colorectal cancer (cancer that has spread to other organs). Researchers want to see if adding this immunotherapy improves outcomes compared to chemotherapy alone. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with metastatic colorectal adenocarcinoma confirmed by biopsy - Your cancer is not treatable with surgery or local therapy - You have not previously received chemotherapy for metastatic disease (neoadjuvant therapy is allowed if it ended more than 12 months ago) - You have at least one measurable tumor area and are in good overall health (ECOG 0-1) **You may NOT be eligible if...** - You have received prior systemic treatment for metastatic colorectal cancer - You have significant heart, liver, or kidney problems - 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

DRUGAK112

iv, q2w

DRUGOxaliplatin

iv, q2w

DRUGIrinotecan

iv, q2w

DRUGLeucovorin and 5-FU

iv, q2w

DRUGBevacizumab

iv, q2w


Locations(2)

The Sixth Hospital,Sun Yat-sen University

Guanzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT06951503


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