Melphalan and Approved Cancer Treatment for Metastatic Colorectal Cancer
This study is looking at people with colorectal cancer that has spread mainly to the liver (liver-dominant metastatic disease) and cannot be removed by surgery. Researchers want to see if giving a high dose of melphalan directly into the liver, followed by standard cancer treatment (trifluridine-tipiracil plus bevacizumab), is safe and effective. They will compare this approach to receiving only the standard cancer treatment. The main goal is to see how long people live without their liver disease getting worse (hepatic progression-free survival, or hPFS) over 24 months. You can join if you are 18 or older and have metastatic colorectal cancer with liver-dominant disease, where liver tumors make up 50% or less of your liver.
- Study design
- This is an open-label, randomized study with about 90 participants. Participants will be randomly assigned to one of two treatment groups.
- What's involved
- You will either undergo up to two liver-directed melphalan procedures followed by approved cancer treatment, or take approved cancer treatment alone. You will visit the clinic at least every two weeks for checkups and tests, and complete scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome (hPFS) will be measured over 24 months from when you are randomly assigned to a treatment group.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06607458
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
Recruiting
PHASE2Ages 18+InterventionalTreatmentDelcath Systems Inc.
~90 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus BevacizumabTrifluridine-tipiracil plus Bevacizumab Alone
At a glance
Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
hPFS
Measured over time from randomization to the first occurrence of hepatic disease progression, assessed over 24 months
Conditions
Where it's being run
14 sites across 12 statesCalifornia2
Germany2
Florida1
Kansas1
Louisiana1
Utah1
Czechia1
Italy1
Study leadership
- Marwan Fakih, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically confirmed diagnosis of metastatic colorectal cancer and histologically or cytologically proven CRC metastases that occupy 50% or less of the liver parenchyma.
Patient has liver-dominant metastatic disease. Liver-dominant is defined as the majority of total tumor burden is located in the liver, and the liver lesions are not resectable or treatable with ablation or are associated with extrahepatic disease that makes surgical intervention non-curative.
Disease in the liver must be measurable (per RECIST v.1.1 guidelines) by computed tomography (CT) and/or magnetic resonance imaging (MRI).
If there is evidence of extrahepatic metastatic disease, it is limited, and the life-threatening component of disease is in the liver. Limited extrahepatic disease is defined in this protocol as follows: up to 5 tumor lesions in the lung with longest diameter not greater than 2 cm and/or up to 5 lymph nodes that measure 2 cm or less per lesion; solitary lesions definitively treated with no sign of progression in the last 6 months.
Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of the liver) must be performed within 28 days prior to randomization.
Previous treatment and progressed on or following, or intolerant to, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and/or an anti-EGFR therapy if RAS wild-type.
ECOG PS of 0-1 within 14 days prior to randomization.
Exclusion
Child-Pugh Class B or C cirrhosis or evidence of clinically significant portal hypertension by history, endoscopy, or radiologic studies (large abdominal varices, prior history of varices by endoscopy).
New York Heart Association functional classification II, III or IV or active cardiac condition(s), including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease that create(s) undue risks of undergoing general anesthesia.
History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
History of bleeding disorders, presence of brain metastases, or other intracranial abnormalities found on baseline radiologic imaging that would put them at risk for bleeding with anti-coagulation.
Known varices at risk of bleeding, including medium or large esophageal or gastric varices, active peptic ulcer, or history of recent hemoptysis.
Active second malignancy, or has history of recently definitively treated invasive cancer in the past 2 years prior to enrolment with the exception of non-melanoma skin cancer.
Peritoneal lesions or large abdominal masses.
Use of immunosuppressive drugs.
Inability to temporarily stop chronic anti-coagulation therapy.
Active bacterial infections with systemic manifestations.
Active viral infection, including Hepatitis B and Hepatitis C infection. NOTE: Patients with anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface antigen (HBsAg) but DNA negative are allowed exception(s).
Severe allergic reaction to iodine contrast that cannot be controlled by premedication with antihistamines and steroids.
History of or known hypersensitivity to melphalan or the components of the melphalan/HDS system.
History of known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
Uncontrolled endocrine disorder including diabetes mellitus, hypothyroidism, or hyperthyroidism.
Received anti-cancer therapy including radiotherapy or investigational agent for any indication ≤ 30 days prior to randomization
Previous treatment with trifluridine-tipiracil.
History of allergic reactions attributed to compounds of similar composition to trifluridine/tipiracil or any of its excipients.
Hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption.
History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.
History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
Contraindications to bevacizumab, including uncontrolled hypertension, history of active fistula or bowel perforation (unless in the setting of a resected primary), history of CVA or arterial thrombotic event in the last 1 year, or history of venous thrombotic event in the last 30 days.
Evidence of hepatic vein or portal vein thrombosis
Prior chemoembolization or radioembolization to the liver or prior hepatic arterial infusion therapy
What this trial measures
- hPFStime from randomization to the first occurrence of hepatic disease progression, assessed over 24 months
Hepatic Progression Free Survival