Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metas… (NCT07441369) | Clinical Trial Compass
By InvitationPhase 2
Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer
China16 participantsStarted 2026-05-01
Plain-language summary
This is a single-center, single-arm, open-label clinical study, to explore the efficacy and safety of abemaciclib combined with FOLFOX/FOLFIRI regimen in patients with advanced colorectal liver metastases cancer who failed standard two or three-line therapy.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Informed consent has been signed
. Histologically or cytologically confirmed unresectable advanced colorectal liver metastases cancer
. Age ≥ 18 years, ≤75 years
. ECOG PS：0-1
. Patients who failed standard two or three-line therapy
. Expected overall survival ≥3 months
. Patients must have at least one measurable liver metastases (RECIST 1.1)
. Patients who have previously failed standard treatment, or who cannot tolerate standard treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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);
. Patients who have previously received CDK inhibitors treatment;
. Patients with obstruction, bleeding or perforation who require surgical or interventional treatment;
. Patients who are allergic or suspected to be allergic to the study drug, similar drugs or drug excipients;
. Patients currently have central nervous system (CNS) metastasis or previous brain metastasis and the symptom control time is less than 2 months;
. 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\[\>1×103 copies/mL\]);
. 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);
. Abnormal coagulation function (INR\>2.3 or APTT\>1.5×ULN), with a bleeding tendency or currently undergoing thrombolytic or anticoagulant therapy;