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New combo therapy offers hope for Tough-to-Treat colorectal liver cancer

NCT ID NCT07441369

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 2 times

Summary

This study tests a combination of the drug abemaciclib with standard chemotherapy (FOLFOX or FOLFIRI) in 16 adults with advanced colorectal cancer that has spread to the liver and hasn't responded to at least two prior treatments. The goal is to see if this combination can shrink tumors and control the disease. Participants will receive the treatment and be monitored for side effects and how long the cancer stays under control.

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 16 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 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 to 75 years

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. Informed consent has been signed 2. Histologically or cytologically confirmed unresectable advanced colorectal liver metastases cancer 3. Age ≥ 18 years, ≤75 years 4. ECOG PS:0-1 5. Patients who failed standard two or three-line therapy 6. Expected overall survival ≥3 months 7. Patients must have at least one measurable liver metastases (RECIST 1.1) 8. Patients who have previously failed standard treatment, or who cannot tolerate standard treatment 9. Patients must have adequate organ and bone marrow function 10. Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration Exclusion Criteria: 1. Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ); 2. Patients who have previously received CDK inhibitors treatment; 3. Patients with obstruction, bleeding or perforation who require surgical or interventional treatment; 4. Patients who are allergic or suspected to be allergic to the study drug, similar drugs or drug excipients; 5. Patients currently have central nervous system (CNS) metastasis or previous brain metastasis and the symptom control time is less than 2 months; 6. Clinical uncontrolled active infections, including human immunodeficiency virus (HIV) infection, active hepatitis B / C (HBV DNA Positive\[1×104 copies/mL or \>2000 IU/ml\], HCV RNA positive\[\>1×103 copies/mL\]); 7. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; NYHA classification \> 2 Grade; ventricular arrhythmia requiring medical therapy; ECG showing QTc interval \> 450 ms (Male) or 470ms (Female); 8. Abnormal coagulation function (INR\>2.3 or APTT\>1.5×ULN), with a bleeding tendency or currently undergoing thrombolytic or anticoagulant therapy; 9. Hereditary or acquired tendency for bleeding and thrombosis, such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism; 10. Within 3 months prior to entering the study, clinically bleeding symptoms or bleeding tendency, such as gastrointestinal bleeding without ligation or sclerotherapy injection, hemorrhagic gastric ulcer, positive Fecal Occult Blood Test (++ or above), or suffering from phlebitis; 11. Arterial/venous thrombotic events that occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 12. Long-term anticoagulation therapy with warfarin or heparin is required, or long-term antiplatelet therapy (aspirin ≥300 mg/ day or clopidogrel ≥75 mg/ day) is needed; 13. Concurrent severe infection within 2 weeks before the first administration (e.g., requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever during screening/before the first administration (\>38.5°C); 14. A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 15. Participating in other clinical trials and received at least one treatment within 3 months before enrollment; 16. A history of abuse or drug use of psychotropic substances; 17. Patients with other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participating in the study or interfere with the research results, as well as those deemed unsuitable for participation in this study by the researchers.

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Conditions

The condition(s) this trial relates to.

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Shanghai Cancer Center

    Shanghai, 200032, China