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

July 20, 2026 updated by: Lu Wang, MD, PhD, Fudan University

Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Two or Three-line Therapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Colorectal Cancer (CRC) is the third most common malignant tumor worldwide, and its mortality rate ranks second globally. Approximately 70% of distant metastases of colorectal cancer occur in the liver, and about 50% of colorectal cancers develop liver metastases (CRLM), which is one of the main factors contributing to the poor prognosis of colorectal cancer. FOLFOX and FOLFIRI regimens are standard therapy for CRLM. Abemaciclib, a FDA approved drug targeting CDK4/6 in breast cancer, also shows anti-tumor activities in other types of solid tumors. In our preclinical experiments, our results also indicated that Abemaciclib conbined with FOLFOX or FOLFIRI regimen showed synergistic anti-tumor activity in CRC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Abemaciclib+ mFOLFOX/FOLFIRI
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
Abemaciclib was administered orally at 100-200mg twice daily for each 28-day cycle.
Other Names:
  • LY2835219
Drug: Oxaliplatin
85mg/m², ivdrip, D1
Other Names:
  • L-OHP
Drug: Calcium Folinate
400mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
Other Names:
  • Leucovorin
Drug: 5-Fluorouracil
400mg/m², iv, D1; and 2400mg/m², civ, 46-48h
Other Names:
  • 5-FU
  • Fluorouracil
Drug: Irinotecan
180mg/m², ivdrip, D1
Other Names:
  • CPT-11

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 12 months
Objective Response Rate
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DCR
Time Frame: 12 months
Disease Control Rate
12 months
TTP
Time Frame: 12 months
Time To Progression
12 months
ADRs
Time Frame: 12 months
Adverse Drug Reactions
12 months
PFS
Time Frame: 12 months
Objective Response Rate
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Cancer Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GWK-2026-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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