NCT07441369

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

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

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Liver Metastases From Colorectal Cancer (mCRC)

Interventions

Type	Name	Description
DRUG	Abemaciclib	Abemaciclib was administered orally at 100-200mg twice daily for each 28-day cycle.
DRUG	Oxaliplatin	85mg/m², ivdrip, D1
DRUG	Calcium Folinate	400mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
DRUG	5-Fluorouracil	400mg/m², iv, D1; and 2400mg/m², civ, 46-48h
DRUG	Irinotecan	180mg/m², ivdrip, D1

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: China