Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer
NCT07441369 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-04-27
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)
Interventions
- DRUG
-
Abemaciclib was administered orally at 100-200mg twice daily for each 28-day cycle.
- DRUG
-
85mg/m², ivdrip, D1
- DRUG
-
Calcium Folinate
400mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
- DRUG
-
400mg/m², iv, D1; and 2400mg/m², civ, 46-48h
- DRUG
-
180mg/m², ivdrip, D1
Sponsors & Collaborators
-
Shanghai Cancer Hospital, China
collaborator OTHER -
Fudan University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
Countries
- China
Study Locations
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