Clinical trial · Observational
Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy
Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP With the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy
NCT03266042CI-TRIAL-00034799unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Malignant Neoplasm Primary Non-Resectable | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).
- timeFrame
- Post-procedure (up to 30 days after CS-PHP)
- description
- Data to be collected at: Baseline, treatment and post treatment laboratory values and clinical measurements until time of discharge
Secondary outcomes (4)
- measure
- Percentage of treatment with CHEMOSAT each patient receives
- timeFrame
- From the first CHEMOSAT treatment through the last, [timeframe an average of 12-months if 6 cycles completed]
- description
- The percentage of treatments with CHEMOSAT each patient receives based on primary tumor
- measure
- Evaluation of Best Overall Response
- timeFrame
- from the date of first CHEMOSAT treatment through last CHEMOSAT treatment, or treatment discontinuation or death (whichever occurs first) [assessed up to 24 months]
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
1. Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to receive treatment with CHEMOSAT. 2. Have provided written informed consent according to institutional and regulatory guidelines
References
Publications (0)
Data not yet available
No reference posted for this study.