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

Conditions

• Liver Metastases From Colorectal Cancer (mCRC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 1, 2026

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

16 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

ORR [ Time Frame: 12 months ]