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

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

Trial Details

NCT ID
NCT06607458
Phase
PHASE2
Sponsor
Delcath Systems Inc.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab
  • Trifluridine-tipiracil plus Bevacizumab Alone
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Santa Monica, California, United States|34.01949,-118.49138
  • Tampa, Florida, United States|27.94752,-82.45843
  • Fairway, Kansas, United States|39.02223,-94.6319
  • Salt Lake City, Utah, United States|40.76078,-111.89105

Key Eligibility Criteria

  • Histologically confirmed diagnosis of metastatic colorectal cancer and histologically or cytologically proven CRC metastases that occupy 50% or les…
  • Patient has liver-dominant metastatic disease. Liver-dominant is defined as the majority of total tumor burden is located in the liver, and the liv…
  • 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 extr…

For full eligibility, visit ClinicalTrials.gov.

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