FOCUS Phase 3 Clinical Trial and Pivotal ICC Trial

Clinical Trials

As part of its mission to make a clinically meaningful difference for patients with cancers of the liver, Delcath Systems is deeply committed to the clinical development of Percutaneous Hepatic Perfusion (PHP®)*. To date, PHP has been the subject of peer-reviewed papers, as well as multiple oral and poster presentations. Additional trials are underway to examine the use of PHP in metastatic ocular melanoma, as well as primary liver cancer (HCC/ICC).

* For Investigational Use Only in the U.S.

FOCUS Phase 3 Clinical Trial (NCT02678572)

The FOCUS trial is designed to evaluate two groups of patients who have melanoma that has spread from the eye to the liver: one group (50 percent) will get high-dose chemotherapy delivered specifically to the liver, while the other group (50 percent) will get one of four standard best alternative care treatments. The study will evaluate the effect of the treatments on survival and how long it takes for the cancer to advance or respond to the treatment. Primary outcome measures:
  • Overall survival
Secondary outcome measures:
  • Progression-free survival as determined by the investigator
  • Objective response rate as determined by the investigator

Who Can Participate

You may be able to join the study if you:
  • Are an adult who weighs at least 80 pounds
  • Have tumors in no more than one-half of the liver
  • Have cancer that has spread to the skin, lung, or bone, as long as it’s limited
  • Have had previous therapies that didn’t work
  • Overall are in good health status (determined by examination and blood work) with an otherwise healthy liver
You are not able to join the study if you:
  • Have cirrhosis of the liver
  • Have active significant heart or lung problems
  • Have had current or past significant bleeding problems
  • Have cancer that has spread to the brain
  • Have diabetes that is not controlled
  • Are Pregnant (women must agree to not get pregnant for 6 months after last study treatment)
For more information on this trial, please visit ClinicalTrials.gov.

Pivotal ICC Trial (NCT03086993)

Delcath reached a Special Protocol Assessment (SPA) agreement with the FDA in March 2017 for the design of a pivotal Phase 3 trial assessing PHP to treat patients with intrahepatic cholangiocarcinoma (ICC). This study will evaluate two groups of patients who have ICC. Each group will receive induction treatment with cisplatin and gemcitabine for 4 treatment cycles. Following induction, 50 percent of patients will undergo PHP treatment and 50 percent will continue treatment with cisplatin and gemcitabine. The study is expected to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. Primary outcome measures:
  • Overall survival
Secondary outcome measures:
  • Progression-free survival as determined by Independent Review Committee
  • Objective response rate as determined by Investigator

Who Can Participate

You may be able to join the study if you:
  • Are an adult
  • Have unresectable ICC involving less than one-half of the liver
  • Have at least one target lesion
You are not able to join the study if you:
  • Have received a liver transplant (Whipple’s procedure may be permitted)
  • Have had prior treatment with gemcitabine or platinum-containing compounds
  • Have brain lesions or intracranial abnormalities
  • Received an investigational agent 30 days prior to first treatment
  • Have an ongoing heart condition
  • Have had current or past significant bleeding problems
  • Are Pregnant (women must agree to not get pregnant for 6 months after last study treatment)
  • Have inadequate liver function
  • Known alcohol abuse
For more information on this trial, please visit ClinicalTrials.gov.


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Disclaimer:

Delcath does not make any claim whatsoever, real or implied, about the efficacy or safety of any therapy, drug, system, or technique under active research.