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RECRUITING Phase 2

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

NCT06607458 · View on ClinicalTrials.gov ↗

Study 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

Interventions

  • DRUG Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab
  • DRUG Trifluridine-tipiracil plus Bevacizumab Alone

Study Locations (10)

Other

  • Czech Republic - University Hospital — Prague
  • Helios Park-Klinikum Leipzig — Leipzig
  • Instiuto Europeo de Oncologia — Milan
  • Clinical Hospital Center "Bezanijska Kosa" — Belgrade
  • Hospital Clinic Barcelona — Barcelona

California

  • City of Hope — Duarte
  • UCLA Hematology/Oncology-Santa Monica — Santa Monica

Florida

  • Moffitt Cancer Center — Tampa

Kansas

  • The University of Kansas Clinical Research Center — Fairway

Utah

  • Huntsman Cancer Institute, University of Utah — Salt Lake City

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2025-08-05
Est. Completion 2027-10
Phase Phase 2

Sponsor

Delcath Systems

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06607458

The ClinicalTrials.gov registry entry for NCT06607458 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Delcath Systems, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Refractory Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06607458 reports 10 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06607458 about?

NCT06607458 is a clinical study titled "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 therap...

What is the current status of trial NCT06607458?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2025-08-05. Estimated completion is 2027-10.

What conditions does trial NCT06607458 study?

This clinical trial studies the following conditions: Refractory Metastatic Colorectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06607458?

The interventions under investigation include: Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab (DRUG), Trifluridine-tipiracil plus Bevacizumab Alone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06607458?

This trial is sponsored by Delcath Systems, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06607458 being conducted?

This trial has 10 study locations across California, Florida, Kansas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial