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 range18 Years – 75 Years
SexALL
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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
Exclusion criteria
✕. 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;