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
← catalyst calendarNCT06607458 · readout ≤ 134 d
Sponsored by Delcath Systems Inc. (industry) · DCTH — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
90estimated
Sites
14
Countries
Czechia, Germany, Italy +5
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-05 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-09-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Refractory Metastatic Colorectal Cancer
Interventions
- Drug: Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab — also filed as Melphalan, HDS, Trifluridine-tipiracil plus Bevacizumab, Trifluridine-tipiracil, Melphalan/HDS
- Drug: Trifluridine-tipiracil plus Bevacizumab Alone — also filed as Trifluridine-tipiracil, Bevacizumab
Primary outcome
what the primary-completion date above is the date OFhPFS
measured time from randomization to the first occurrence of hepatic disease progression, assessed over 24 months
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