The Efficacy and Safety of Lcaritin Combined With Bevacizumab and FOLFIRI in Treatment of Liver Metastases From Colorectal Cancer
- Sponsor
- Sir Run Run Shaw Hospital
- Study ID
- NCT06269445
- Phase
- PHASE4
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Icaritin Combined With Bevacizumab and FOLFIRI — DRUGBevacizumab and FOLFIRI are second-line treatment options for colorectal cancer; synergistic efficacy expected in combination with Icaritin
Study Details
To evaluate the efficacy and safety of the combination regimen of Icaritin with bevacizumab + FOLFIRI in patients with liver metastases from advanced colorectal cancer.
Key Dates
- First listed
- Feb 21, 2024
- Start date
- Jan 1, 2024
- Status verified
- Feb 2024
- Primary completion
- Feb 1, 2025
- Completion
- Feb 1, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Icaritin Combined With Bevacizumab and FOLFIRIIcaritin: 600 mg orally, bid; Bevacizumab: Intravenous infusion, 5 mg/kg per dose, every 14 days; FOLFIRI: ①Irinotecan: Irinotecan should be given on the first day of chemotherapy at a dose of 180mg/m2 by intravenous drip.The infusion time should be \>30-90min. ②Calcium folinate: give irinotecan at a dose of 400mg/m2 by intravenous drip in conjunction with irinotecan infusion, and the infusion time should be up to 2h. ③5-fluorouracil: give intravenous infusion at a dose of 400mg/m2 on the first day of chemotherapy, then give an intravenous drip at a dose of 1200mg/m2 for 2 days, the total amount of 2400mg/m2 , and continue to be infused for 46-48h.
Primary Outcome Measure
Progression-free survival(PFS) [ Time Frame: up to 5 years ]
Central Contacts
- Fei Wang13732236150
Related Studies
- Evaluation for NCI Surgery Branch Clinical Research ProtocolsRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer PatientsRecruiting · Vanderbilt University Medical Center · Nashville, Tennessee
- ColoCare Study - Colorectal Cancer CohortRecruiting · University of Utah · Los Angeles, California
- Feasibility of the LUM Imaging System for Detection of Gastrointestinal CancersPHASE1/PHASE2 · Recruiting · Lumicell, Inc. · Boston, Massachusetts