Actively Recruiting
Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease
Led by Delcath Systems Inc. · Updated on 2026-03-13
90
Participants Needed
10
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with colorectal cancer that has spread to the liver is safe and tolerable. The clinical trial will also learn if the liver-directed therapy with high dose chemotherapy works on the disease in the liver. Investigators will compare the use of the liver-directed therapy with high dose chemotherapy followed by approved cancer treatment or approved cancer treatment alone. Participants will: * Undergo up to two liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone * Visit clinic at least every two weeks for checkups and tests * Complete scans approximately every two months
CONDITIONS
Official Title
Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic colorectal cancer with 50% or less liver involvement
- Liver-dominant metastatic disease with non-resectable or non-curative liver lesions
- Measurable liver disease by CT or MRI using RECIST v1.1
- Limited extrahepatic disease if present, with specific size and number limits
- Required scans within 28 days before randomization
- Prior treatment with fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, anti-VEGF therapy, and/or anti-EGFR therapy if RAS wild-type
- ECOG performance status of 0 or 1 within 14 days before randomization
You will not qualify if you...
- Child-Pugh Class B or C cirrhosis or significant portal hypertension
- New York Heart Association class II-IV or active serious cardiac conditions
- Significant pulmonary disease preventing general anesthesia
- History of bleeding disorders or brain metastases increasing bleeding risk
- Known varices at risk of bleeding or active peptic ulcers
- Active second cancer or recent invasive cancer treated within 2 years (except non-melanoma skin cancer)
- Peritoneal lesions or large abdominal masses
- Use of immunosuppressive drugs
- Inability to temporarily stop chronic anti-coagulation therapy
- Active systemic bacterial or viral infections including Hepatitis B or C (with some exceptions)
- Severe allergy to iodine contrast or melphalan/HDS system
- Hypersensitivity to heparin or history of heparin-induced thrombocytopenia
- Uncontrolled endocrine disorders
- Anti-cancer therapy within 30 days prior to randomization
- Prior treatment with trifluridine-tipiracil or hypersensitivity to its components
- Hereditary galactose intolerance or related disorders
- Hypersensitivity to bevacizumab or similar antibodies
- Contraindications to bevacizumab including uncontrolled hypertension or recent thrombotic events
- Hepatic vein or portal vein thrombosis
- Prior liver chemoembolization, radioembolization, or hepatic arterial infusion therapy
AI-Screening
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Trial Site Locations
Total: 10 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
UCLA Hematology/Oncology-Santa Monica
Santa Monica, California, United States, 90404
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
The University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
5
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
6
Czech Republic - University Hospital
Prague, Czechia
Actively Recruiting
7
Helios Park-Klinikum Leipzig
Leipzig, Germany
Actively Recruiting
8
Instiuto Europeo de Oncologia
Milan, Italy
Actively Recruiting
9
Clinical Hospital Center "Bezanijska Kosa"
Belgrade, Serbia, 11080
Actively Recruiting
10
Hospital Clinic Barcelona
Barcelona, Spain
Actively Recruiting
Research Team
M
Matthew Cooney, MD
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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