Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer

NCT07441369 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: GWK-2026-002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Metastases From Colorectal Cancer (mCRC)

Keywords

Abemaciclib; FOLFOX; FOLFIRI; Advanced Colorectal Liver Metastases Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-Free Survival

  12 months

Secondary Outcomes (4)

• ORR

  12 months

• DCR

  12 months

• TTP

  12 months

• ADRs

  12 months

Study Arms (1)

Abemaciclib+ mFOLFOX/FOLFIRI

EXPERIMENTAL

Abemaciclib was administered orally at 100-200mg twice daily for each 28-day cycle. mFOLFOX6 and FOLFIRI will be administered every 2-4 weeks.

Drug: Abemaciclib; Drug: Oxaliplatin; Drug: Calcium Folinate; Drug: 5-Fluorouracil; Drug: Irinotecan

Interventions

Abemaciclib DRUG

Abemaciclib was administered orally at 100-200mg twice daily for each 28-day cycle.

Also known as: LY2835219

Abemaciclib+ mFOLFOX/FOLFIRI

Oxaliplatin DRUG

85mg/m², ivdrip, D1

Also known as: L-OHP

Abemaciclib+ mFOLFOX/FOLFIRI

Calcium Folinate DRUG

400mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1

Also known as: Leucovorin

Abemaciclib+ mFOLFOX/FOLFIRI

5-Fluorouracil DRUG

400mg/m², iv, D1; and 2400mg/m², civ, 46-48h

Also known as: Fluorouracil, 5-FU

Abemaciclib+ mFOLFOX/FOLFIRI

Irinotecan DRUG

180mg/m², ivdrip, D1

Also known as: CPT-11

Abemaciclib+ mFOLFOX/FOLFIRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients must have adequate organ and bone marrow function
• 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

You may not qualify if:

• 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;
• Hereditary or acquired tendency for bleeding and thrombosis, such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism;
• 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;
• 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;
• 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;
• 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);
• A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Participating in other clinical trials and received at least one treatment within 3 months before enrollment;

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Cancer Hospital, China: collaborator

Study Sites (1)

Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Interventions

abemaciclib; Oxaliplatin; Leucovorin; Fluorouracil; Irinotecan

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Director of Hepatic Surgery

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: March 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)