Clinical Trial: Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine Versus Cisplatin/Gemcitabine in Patients

Brief Summary: This study will evaluate two groups of patients who have intrahepatic cholangiocarcinoma. Each group will receive induction treatment with Cisplatin and Gemcitabine per SOC for 4 treatment cycles. Following induction treatment patients will be randomize (1:1), to 2 arms of treatment. One group (50%) will be receive high dose chemotherapy delivered specifically to the liver, while the other group (50%) will continue treatment with Cisplatin and Gemcitabine. Patient in each group will get repeating cycles of treatment until the cancer advances. All patients will be followed until death. This study will compare the overall survival (OS) in patients with intrahepatic cholangiocarcinoma.

Detailed Summary:

The study will consist of 4 phases: a screening, an induction, randomization and follow-up phase.

Screening phase: Screening assessments will be conducted within 28 days prior to initiation of Induction Phase treatment to determine each patient's overall eligibility. These assessments will include medical history; physical examination; Eastern Cooperative Oncology Group (ECOG) performance status (PS); 12 lead electrocardiogram (ECG); echocardiogram (ECHO); vital signs; laboratory assessments; radiologic assessments of disease status; and an evaluation of the vasculature compatibility for Percutaneous Hepatic Perfusion (PHP).

Induction phase: The initial 12 weeks of the study, all patients will receive 4 cycles of cisplatin/gemcitabine. Each cycle will be comprised of cisplatin dosed at 25 mg per square meter of body-surface area (BSA), followed by gemcitabine dosed at 1000 mg per square meter of BSA; dosing will occur on Days 1 and 8 of each cycle. At the completion of 3 cycles (week 8 (+1 week)) of cisplatin/gemcitabine, an imaging scan is performed as per standard of care to determine if the patient has progressed on treatment or should continue receiving the cisplatin/gemcitabine induction therapy for one more cycle (4th cycle - prior to randomization). At the completion of 4 cycles (week 12 (+1 week)) of cisplatin/gemcitabine, patients will undergo whole-body imaging to determine the status of their disease. Patients with progressive disease (PD) will be discontinued from study treatment, and will receive further treatment to be determined by the principal investigator (PI). They will continue to be followed until death or the end of the study. Patients who have at least stable disease (SD) at imaging after induction phase of 4 cycles of cisplatin/gemcitabine (week 12 (+ 1 week)) will go on to the next phase of the stu
Sponsor: Delcath Systems Inc.

Current Primary Outcome: Overall Survival [ Time Frame: Change in survival is being assessed through study completion, an average of 2 years ]

Patients will be followed until death


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression-free survival, as determined by IRC [ Time Frame: Change in PFS change will be assessed every 9 weeks through study completion, an average of 1 year ]
    Period of time from 1st treatment to tumor progression or death
  • Objective response rate (CR + PR) as determined by the Investigator [ Time Frame: ORR change will be assessed every 9 weeks through study completion, an average of 1 year ]
    The number of patients with either a complete or partial response as determined by the investigator


Original Secondary Outcome: Same as current

Information By: Delcath Systems Inc.

Dates:
Date Received: March 13, 2017
Date Started: September 2017
Date Completion: May 2023
Last Updated: March 21, 2017
Last Verified: March 2017