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Liver Metastases From Colorectal Cancer (mCRC)Phase 2NCT07441369

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

A Phase 2 study testing Abemaciclib, Oxaliplatin and Calcium Folinate in people with Liver Metastases From Colorectal Cancer (mCRC), run by Fudan University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Abemaciclib, Oxaliplatin and Calcium Folinate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
30 Jul 2026to 30 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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]);
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  • 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;
  • A history of abuse or drug use of psychotropic substances;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Abemaciclib, Oxaliplatin, Calcium Folinate, 5-Fluorouracil, Irinotecan
Keywords
Abemaciclib, FOLFOX, FOLFIRI, Advanced Colorectal Liver Metastases Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    Also called LY2835219

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

  • OxaliplatinDrug

    Also called L-OHP

    85mg/m², ivdrip, D1

  • Calcium FolinateDrug

    Also called Leucovorin

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

  • 5-FluorouracilDrug

    Also called Fluorouracil, 5-FU

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

  • IrinotecanDrug

    Also called CPT-11

    180mg/m², ivdrip, D1

Study groups in NCT07441369
Study groupRoleWhat they receive
Abemaciclib+ mFOLFOX/FOLFIRIExperimentalAbemaciclib was administered orally at 100-200mg twice daily for each 28-day cycle. mFOLFOX6 and FOLFIRI will be administered every 2-4 weeks.
Receives: Drug: Abemaciclib; Drug: Oxaliplatin; Drug: Calcium Folinate; Drug: 5-Fluorouracil; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective Response Rate

    Measured: 12 months

Secondary outcomes (4)

  1. PFS

    Objective Response Rate

    Measured: 12 months

  2. DCR

    Disease Control Rate

    Measured: 12 months

  3. TTP

    Time To Progression

    Measured: 12 months

  4. ADRs

    Adverse Drug Reactions

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2026
  2. Study start30 Jul 2026 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07441369
Sponsor's protocol ID
GWK-2026-002
Status last verified
Jul 2026
First submitted
22 Feb 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib, Oxaliplatin and Calcium Folinate in people with Liver Metastases From Colorectal Cancer (mCRC), run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07441369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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