RecruitingPhase 2NCT06607458

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

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients With Refractory Metastatic Colorectal Cancer With Liver Dominant Disease


Sponsor

Delcath Systems Inc.

Enrollment

90 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a procedure called hepatic melphalan delivery — where a high dose of chemotherapy is delivered directly into the liver's blood supply — in combination with standard approved cancer treatments for people with metastatic colorectal cancer that has spread mainly to the liver. **You may be eligible if...** - You have been diagnosed with metastatic colorectal cancer confirmed by biopsy - The majority of your cancer burden is in the liver, and the liver tumors cannot be surgically removed or ablated - Your liver tumors take up 50% or less of the liver volume - Any cancer outside the liver is limited, and the liver disease is the most life-threatening component - Your liver lesions are measurable on CT or MRI **You may NOT be eligible if...** - Cancer outside the liver is extensive or life-threatening in its own right - Your liver lesions occupy more than 50% of the liver - You have significant health conditions that would make the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMelphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab

Trifluridine-tipiracil plus Bevacizumab Alone

DRUGTrifluridine-tipiracil plus Bevacizumab Alone

Trifluridine-tipiracil plus Bevacizumab Alone


Locations(10)

City of Hope

Duarte, California, United States

UCLA Hematology/Oncology-Santa Monica

Santa Monica, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

The University of Kansas Clinical Research Center

Fairway, Kansas, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Czech Republic - University Hospital

Prague, Czechia

Helios Park-Klinikum Leipzig

Leipzig, Germany

Instiuto Europeo de Oncologia

Milan, Italy

Clinical Hospital Center "Bezanijska Kosa"

Belgrade, Serbia

Hospital Clinic Barcelona

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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NCT06607458


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