Delcath Systems, Inc. ((DCTH)) announced an update on their ongoing clinical study.
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Delcath Systems, Inc. has announced a new clinical study titled An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Eribulin or Vinorelbine or Capecitabine Versus Eribulin or Vinorelbine or Capecitabine Alone in Patients With Metastatic Breast Cancer With Liver Dominant Disease. The study aims to assess the safety and efficacy of a liver-directed therapy using high-dose chemotherapy for patients with metastatic breast cancer that has spread to the liver. This research is significant as it explores potential advancements in treatment options for this challenging condition.
The intervention being tested is Melphalan/HDS, a high-dose chemotherapy delivered directly into the liver, followed by a physician’s choice of standard of care (SOC) treatments such as eribulin, vinorelbine, or capecitabine. The purpose is to determine whether this combination is more effective than SOC treatments alone.
The study is designed as a randomized, parallel assignment with no masking, focusing primarily on treatment. Participants will be randomly assigned to receive either the experimental treatment or the standard care, with the primary goal of evaluating treatment efficacy and safety.
The study is set to begin on March 6, 2025, with the primary completion and estimated study completion dates yet to be announced. The last update was submitted on May 19, 2025, indicating the study is in its early stages and not yet recruiting participants.
This update from Delcath Systems could influence investor sentiment and stock performance, as successful outcomes may enhance the company’s market position in the oncology sector. Competitors in the field should monitor these developments closely, as advancements in treatment options could shift market dynamics.
The study is ongoing, with further details available on the ClinicalTrials portal.