New drug combo aims to shrink liver tumors in colorectal cancer patients
NCT ID NCT06848842
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the drug ivonescimab to standard chemotherapy can shrink liver tumors in people with colorectal cancer that has spread only to the liver and cannot be surgically removed. About 40 adults will receive the combination every 3 weeks for up to 8 cycles. The goal is to see if the tumors shrink enough to allow surgery or to control the disease. Researchers will also monitor side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years. 2. Histologically confirmed colorectal adenocarcinoma. 3. Radiologically confirmed liver-only metastases. Patients with ≤1 cm extrahepatic lesions not confirmed as metastatic are eligible. 4. No prior systemic therapy or local therapy for metastatic lesions, or completion of neoadjuvant/adjuvant chemotherapy ≥6 months before diagnosed disease recurrence. 5. Liver metastases considered unresectable or borderline resectable by multidisciplinary evaluation. 6. Liver metastases were measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 7. Eastern Cooperative Oncology Group performance status 0-1 8. Life expectancy ≥12 weeks. 9. No contraindications to hepatic resection/ablation, and primary tumor resectable or previously resected. 10. Adequate organ function as determined by normal bone marrow function (hemoglobin ≥80 g/L, absolute neutrophil count ≥1.5×10⁹/L, and platelets ≥100×10⁹/L), renal function (serum creatinine ≤1.5×upper limit of normal \[ULN\] and creatinine clearance ≥30 mL/min), liver function (serum bilirubin ≤2×ULN and serum transaminases ≤5×ULN). Exclusion Criteria: 1. Definite extrahepatic metastases. 2. dMMR or MSI-H colorectal cancer. 3. Intolerance to the study drug during prior neoadjuvant/adjuvant therapy. 4. Toxicities from prior therapy have not resolved to ≤ Grade 1 (according to NCI-CTCAE v5.0), except for alopecia (any grade) and peripheral neuropathy (≤ Grade 2). 5. History of or concurrent other malignancies within the past 5 years, except cured localized tumors. 6. Surgery performed within 28 days prior to enrollment. 7. Hypertension with systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg despite antihypertensive treatment. 8. Major cardiovascular events within 12 months prior to enrollment. 9. History of severe bleeding tendency or coagulation disorders; tumor encasement of major blood vessels or significant necrosis or cavitation, and the investigator deems participation in the study may pose a bleeding risk. 10. Active autoimmune disease requiring systemic treatment within the past 2 years. 11. History of immunodeficiency, positive HIV antibody test, or long-term use of corticosteroids or other immunosuppressants. 12. Prior history of allogeneic bone marrow or organ transplantation. 13. Received live vaccines within 30 days prior to the first dose or plans to receive live vaccines during the study period. 14. Allergy to any component of the study drugs; history of severe hypersensitivity reactions to other monoclonal antibodies. 15. Women who are pregnant or breastfeeding. 16. Severe comorbidities or any other condition that precludes safe administration of the study treatment, including but not limited to symptomatic congestive heart failure (Class II or higher per NYHA classification), unstable angina, acute myocardial ischemia, poorly controlled arrhythmias, decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric/social conditions that may limit compliance with study requirements or impair the subject's ability to provide written informed consent. 17. Any other condition deemed by the investigator as unsuitable for participation in this study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITINGBeijing, China
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