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NCT06607458 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Refractory Metastatic Colorectal Cancer, sponsored by Delcath Systems.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 10
- Study locations
NCT06607458 is a Phase 2 study of Refractory Metastatic Colorectal Cancer that is actively recruiting participants, run by Delcath Systems. The registered enrollment target is 90 participants. The trial reports 10 study locations across 5 states.
The verdict
NCT06607458, a Phase 2 study of Refractory Metastatic Colorectal Cancer, is actively recruiting participants, sponsored by Delcath Systems.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 10
- Study locations
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-08-05 |
| Est. Completion | 2027-10 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. 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 6 total studies on file at ClinicalTrials.gov.
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.
NCT06607458 reports 10 study locations spanning 5 distinct geographic areas - top geographies include Other, California, Florida.
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.
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).
Who is sponsoring clinical trial NCT06607458?
This trial is sponsored by Delcath Systems, which has 6 total clinical trials registered on ClinicalTrials.gov.
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.
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