Colorectal Cancer Liver Metastases study: Regorafenib and DIBIRI vs Regorafenib
Official title Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases
ClinicalTrials.gov ID: NCT05794971
What this study is testing
What is Regorafenib and DIBIRI?
Regorafenib and DIBIRI is an investigational medicine, being studied as a potential treatment for colorectal cancer liver metastases.
Also referred to as Drug: Irinotecan, Procedure: TACE.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a trial, aims to look at how well it works and how safe it is of Irinotecan Drug-Eluting Beads combined with regorafenib as the third-line treatment for a patient with colorectal cancer liver metastases.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give...
- Patients failing first- and second-line standard systemic chemotherapy.
- Patients with at least one measurable liver metastases, with size \> 1cm response evaluation criteria in solid tumors (RECIST)
- Patients with liver dominant disease defined as ≥80% tumor body burden confined to the liver
- Less than 60% liver tumor replacement
You likely can't join if
- Prior treatment with TACE, regorafenib or fruquintinib
- Patients with brain metastases
- With serious heart, kidney, bone marrow, or lung, central nervous system diseases.
- Patients suffered with other cancer.
- patients who were seriously ill and had history of chronic disease such as tuberculosis (TB) and human immunodeficiency virus (HIV)/acquired immune...
- known or suspected history of allergy to any of the related drugs used in the study
See the full eligibility criteria
- Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
- Patients failing first- and second-line standard systemic chemotherapy.
- Patients with at least one measurable liver metastases, with size \> 1cm response evaluation criteria in solid tumors (RECIST)
- Patients with liver dominant disease defined as ≥80% tumor body burden confined to the liver
- Less than 60% liver tumor replacement
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of \< 2
- Child-pugh's grade A or B
- Life expectancy of \> 3 months
- Non-pregnant with an acceptable contraception in premenopausal women.
- Hematologic function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, white cell count (WBC) ≥ 3.0 x 109/L, platelets ≥75 x109/L, international normalized ratio (INR) ≤1.3.
- Adequate hepatic and renal function: Alanine aminotransferase (ALT) or aspartate aminotransferase ≤2.5×above upper normal range, total bilirubin≤1.5×above upper normal range, Serum creatinine≤1.5×above upper normal range
- Women of child bearing potential and fertile men are required to use effective contraception negative serum beta human chorionic gonadotropin (βHCG)
- Signed, written informed consent
- Prior treatment with TACE, regorafenib or fruquintinib
- Patients with brain metastases
- With serious heart, kidney, bone marrow, or lung, central nervous system diseases.
- Patients suffered with other cancer.
- patients who were seriously ill and had history of chronic disease such as tuberculosis (TB) and human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) were excluded from the study.
- known or suspected history of allergy to any of the related drugs used in the study
- Women who are pregnant or breast feeding
- Patients with serious somatic or psychiatric illness regarded as contraindications or in need of treatment that would interfere with study participation.
The study team makes the final eligibility decision.
Where it is enrolling
- Guangdong, Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Guangdong, Guangzhou, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.