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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-13

No results posted yet for this 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

  • Refractory Metastatic Colorectal Cancer

Interventions

DRUG

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

Trifluridine-tipiracil plus Bevacizumab Alone

DRUG

Trifluridine-tipiracil plus Bevacizumab Alone

Trifluridine-tipiracil plus Bevacizumab Alone

Sponsors & Collaborators

  • Delcath Systems Inc.

    lead INDUSTRY

Principal Investigators

  • Marwan Fakih, MD · City of Hope Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2026-12-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Italy
  • Serbia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06607458 on ClinicalTrials.gov