Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Refractory Metastatic Colorectal Cancer, sponsored by Delcath Systems.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Hepatic Progression Free Survival
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 |
What NCT06607458 shows while recruiting
NCT06607458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
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 lists 10 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Refractory Metastatic Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06607458's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,200 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI