Actively Recruiting
Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases
Led by Sun Yat-sen University · Updated on 2023-05-15
126
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicentre, prospective, randomised trial, aims to evaluate the efficacy and safety of Irinotecan Drug-Eluting Beads combined with regorafenib as the third-line treatment for a patient with colorectal cancer liver metastases. The study is planned to enrolled 126 patients failing first- and second-line standard chemotherapy treatment.
CONDITIONS
Official Title
Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Histologic or radiologic proof of colorectal cancer with liver metastases
- Failed first- and second-line standard systemic chemotherapy
- At least one measurable liver metastasis larger than 1 cm
- Liver dominant disease with 80% or more tumor burden confined to the liver
- Less than 60% liver tumor replacement
- Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 2
- Child-Pugh grade A or B liver function
- Life expectancy greater than 3 months
- Non-pregnant with acceptable contraception in premenopausal women
- Hematologic function with ANC ≥ 1.5 x 10^9/L, WBC ≥ 3.0 x 10^9/L, platelets ≥ 75 x 10^9/L, INR ≤ 1.3
- Adequate liver and kidney function with ALT or AST ≤ 2.5 times upper normal limit, total bilirubin ≤ 1.5 times upper normal limit, serum creatinine ≤ 1.5 times upper normal limit
- Effective contraception and negative serum beta human chorionic gonadotropin (βHCG) for women of childbearing potential and fertile men
- Signed, written informed consent
You will not qualify if you...
- Prior treatment with TACE, regorafenib, or fruquintinib
- Presence of brain metastases
- Serious heart, kidney, bone marrow, lung, or central nervous system diseases
- History of other cancers
- Serious chronic diseases such as tuberculosis (TB) or HIV/AIDS
- Known or suspected allergy to study drugs
- Pregnant or breastfeeding women
- Serious somatic or psychiatric illness that contraindicates participation or requires treatment interfering with the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Bo Zhang
Guangdong, Guangzhou, China
Actively Recruiting
Research Team
B
Bo Zhang, M.D
CONTACT
B
Bo Zhang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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