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Compares treatment options for Colorectal Cancer Metastatic
Official title FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients
ClinicalTrials.gov ID: NCT05727163
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer metastatic.
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 prospective, randomized, controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases.
- Phase 2: a mid-size study of how well it works
- 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 75
You may be able to join if
- Histologically confirmed colorectal adenocarcinoma
- Imaging or pathological confirmation of liver metastases
- The multidisciplinary team determined that the liver metastases were unresectable, defined as (i) ≥5 metastases; (ii) inability to perform R0...
- Patients with mutated RAS and BrafV600E
- No previous treatment for liver metastases, including chemotherapy, surgery, radiotherapy, transarterial chemoembolization (TACE) and targeted therapy
You likely can't join if
- (Patients meeting any of the following criteria will be excluded from the study):
- Presence of any extrahepatic metastases and/or primary tumor not amenable to radical surgical resection
- Development of liver metastases within 1 year after completion of adjuvant chemotherapy with FOLFOX or XELOX
- Severe arterial embolism or ascites
- Bleeding tendency or coagulation disorder
- Hypertensive crisis or hypertensive encephalopathy
See the full eligibility criteria
- Histologically confirmed colorectal adenocarcinoma
- Imaging or pathological confirmation of liver metastases
- The multidisciplinary team determined that the liver metastases were unresectable, defined as (i) ≥5 metastases; (ii) inability to perform R0 resection; (iii) insufficient volume of liver expected to remain after...
- Patients with mutated RAS and BrafV600E
- No previous treatment for liver metastases, including chemotherapy, surgery, radiotherapy, transarterial chemoembolization (TACE) and targeted therapy
- No extrahepatic metastases confirmed by CT, MRI, or PET/CT (if necessary) (consider enrollment if there is a lung or lymph node lesion less than 10 mm and metastases are difficult to identify)
- Normal hematological function (platelets \>90×109/L; white blood cells \>3×109/L; neutrophils \>1.5×109/L)
- Serum bilirubin ≤ 1.5 times the upper limit of normal value (ULN), transaminases ≤ 5 times ULN
- No ascites, normal coagulation function, albumin ≥35g/L
- Liver function Child-Push grade A
- Serum creatinine less than upper limit of normal (ULN) or calculated creatinine clearance \>50 ml/min (using Cockcroft-Gault formula)
- ECOG score 0-1
- Life expectancy \> 3 months
- Signed written informed consent
- (Patients meeting any of the following criteria will be excluded from the study):
- Presence of any extrahepatic metastases and/or primary tumor not amenable to radical surgical resection
- Development of liver metastases within 1 year after completion of adjuvant chemotherapy with FOLFOX or XELOX
- Severe arterial embolism or ascites
- Bleeding tendency or coagulation disorder
- Hypertensive crisis or hypertensive encephalopathy
- Severe uncontrolled systemic complications such as infections or diabetes mellitus
- Clinically significant cardiovascular disease such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite...
- History or physical examination revealing a central nervous system disease (e.g., primary brain tumor, epilepsy not manageable by standard therapy, presence of brain metastases, or history of stroke)
- Previous malignancy within the last 5 years (except post-radical surgery basal cell carcinoma of the skin and/or carcinoma in situ of the cervix)
- Treatment using any investigational drug within the last 28 days prior to the study
- Any residual toxicity from prior chemotherapy (except alopecia), such as peripheral neuropathy ≥ NCI CTC v3.0 grade 2, will not be considered for treatment with oxaliplatin-containing regimens
- History of allergy to any of the drugs in the study
- Women of childbearing potential (\<2 years after last menstruation) or men of childbearing potential who are not using or have refused to use an effective non-hormonal contraceptive (IUD, barrier method combined with...
- Unable or unwilling to comply with the study protocol
- Presence of any other disease, dysfunction due to metastatic lesions, or suspicious medical findings that suggest a possible contraindication to the use of the study drug or that would place the patient at risk of...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 - 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.