Trial · NCT06607458
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, Phase 2, Recruiting, Delcath Systems Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. 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. Trials, record NCT06607458. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06607458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT06607458
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 90 participants, estimated
- Lead sponsor
- Delcath Systems Inc.
- Conditions
- Refractory Metastatic Colorectal Cancer
- Interventions
- Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab, Trifluridine-tipiracil plus Bevacizumab Alone
- First posted
- 2024-09-23
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | hPFS | time from randomization to the first occurrence of hepatic disease progression, assessed over 24 months | Hepatic Progression Free Survival |
| Secondary | PFS | time from randomization to the first occurrence of progression, assessed up to 24 months | Progression Free Survival |
| Secondary | OS | time from randomization date to the date of death due to any cause, assessed up to 36 months | Overall Survival |
| Secondary | ORR | Baseline through completion of treatment, assessed up to 24 months | Overall Response Rate complete response \[CR\] + partial response \[PR\] |
| Secondary | hORR | assessed from Baseline until there is evidence of disease progression in the liver, assessed up to 24 months | Hepatic Overall Response Rate |
| Secondary | DOR | assessed from Baseline until there is evidence of disease progression, assessed up to 24 months | Duration of Response |
| Secondary | DCR | complete response of any duration, partial response of any duration, or stable disease for a minimum of 12 weeks from randomization date, assessed up to 24 months | Disease Control Rate |
| Secondary | hDOR | assessed from Baseline until there is evidence of hepatic disease progression, assessed up to 24 months | Hepatic Duration of Response |
| Secondary | hDCR | complete hepatic response of any duration, partial response of any duration, or stable disease for a minimum of 12 weeks from randomization date, assessed up to 24 months | Hepatic Disease Control Rate |
| Other | Safety and Tolerability | assessed from signed informed consent form until study completion | Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) Changes from baseline in physical examination findings, vital signs, clinical laboratory parameters, electrocardiogram (ECG) and echocardiogram (ECHO) parameters |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06607458
GET https://conductscience.org/api/trials/v1/NCT06607458/registered