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New drug combo aims to shrink liver tumors in colorectal cancer patients

NCT ID NCT06848842

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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

    RECRUITING

    Beijing, China

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