Delcath Systems’ Promising Study on Liver-Directed Chemotherapy for Colorectal Cancer

Delcath Systems, Inc. ((DCTH)) announced an update on their ongoing clinical study.

Delcath Systems, Inc. is conducting a 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 Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients With Refractory Metastatic Colorectal Cancer With Liver Dominant Disease.’ The study aims to assess the safety and effectiveness of a liver-directed high-dose chemotherapy treatment followed by standard cancer therapy compared to standard therapy alone in patients with metastatic colorectal cancer that has spread to the liver.

The intervention being tested is Melphalan/HDS, a high-dose chemotherapy administered directly into the liver, followed by Trifluridine-tipiracil plus Bevacizumab. This combination is compared against the standard treatment of Trifluridine-tipiracil plus Bevacizumab alone.

This Phase 2 study is interventional, with a randomized allocation and a parallel intervention model. It is open-label, meaning no masking is involved, and its primary purpose is treatment-focused.

The study commenced on September 14, 2024, with its primary completion and estimated completion dates yet to be announced. The latest update was submitted on August 15, 2025, indicating ongoing recruitment.

The outcome of this study could significantly influence Delcath Systems’ stock performance, as positive results may enhance investor confidence and position the company favorably against competitors in the cancer treatment market. The study’s progress is crucial for stakeholders monitoring advancements in liver-targeted cancer therapies.

The study is currently recruiting, with further details available on the ClinicalTrials portal.