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 now · Phase 2

Conditions studied: Refractory Metastatic Colorectal Cancer

In brief

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

Key facts

Study ID

NCT06607458

Run by

Delcath Systems Inc.

People needed

90

Starts

2025-08-05

Expected to finish

2027-10-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• UCLA Hematology/Oncology-Santa Monica — Santa Monica, California, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• The University of Kansas Clinical Research Center — Fairway, Kansas, United States (enrolling)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
• Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (enrolling)
• Czech Republic - University Hospital — Prague, Czechia (enrolling)
• Medizinische Hochschule Hannover — Hanover, Germany (enrolling)
• Helios Park-Klinikum Leipzig — Leipzig, Germany (enrolling)
• Instiuto Europeo de Oncologia — Milan, Italy (enrolling)
• Leiden University Medical Center (LUMC) — Leiden, Netherlands (enrolling)
• Clinical Hospital Center "Bezanijska Kosa" — Belgrade, Serbia (enrolling)
• Hospital Clinic Barcelona — Barcelona, Spain (enrolling)
• Izmir Ekonomi — Izmir, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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