RecruitingPhase 2NCT06848842

Ivonescimab Plus Chemotherapy in Patients With Initially Unresectable Colorectal Cancer Liver Metastases

A Phase II Clinical Study of Ivonescimab Plus CAPOX Regimen in Patients With Initially Unresectable Colorectal Cancer Liver-only Metastases

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

40 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal Liver Metastases

Summary

The goal of this clinical trial is to learn if ivonescimab plus chemotherapy works to treat colorectal cancer liver metastases that cannot be completely removed. It will also learn about the safety of ivonescimab. The main questions it aims to answer are: Does ivonescimab plus chemotherapy raise the objective response rate? What medical problems do participants have when receiving ivonescimab plus chemotherapy? Participants will: Receive ivonescimab and chemotherapy every 3 weeks, no more than 8 cycles. Visit the clinic once every 2 cycles (6 weeks) for checkups and tests. Receive curative surgery, maintenance therapy, or discontinue study treatment according to the expert team's evaluation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ivonescimab (a new drug that blocks both PD-1 immune checkpoint and blood vessel growth signals) combined with chemotherapy can shrink liver metastases enough to make them surgically removable in patients with colorectal cancer that has spread only to the liver. **You may be eligible if...** - You are 18 years of age or older - You have colorectal cancer confirmed by biopsy - Your cancer has spread only to the liver, confirmed by imaging - Your liver metastases are currently not surgically removable - You have not had any prior treatment for your metastatic disease **You may NOT be eligible if...** - Your cancer has spread to organs other than the liver (except very small lesions not confirmed as metastatic) - You have previously received chemotherapy or targeted therapy for metastatic disease - You have serious heart, liver, or immune system conditions - 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

DRUGIvonescimab plus chemotherapy

Ivonescimab, 20mg/kg, D1, Q3W; Oxaliplatin, 130mg/m2, D1, Q3W; Capecitabine, 1000mg/m2, BID, D1-D14, Q3W

Locations(1)

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

Beijing, China

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NCT06848842

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