Infusion System for Hepatic Cancer

Related Clinical Trial
Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery DEB-TACE Combined With Apatinib and PD-1 for the Treatment of Intrahepatic Cholangiocarcinoma Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma Infusion System for Hepatic Cancer Phase II-III Clinical Trial of PD1 Antibody (Toripalimab), Lenvatinib and GEMOX Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial) A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk IHCC in Korea Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma With High Predict Risk of Lymph Node Metastasis Hepatic Artery Infusion (HAI) Program at Duke University Camrelizumab in Combination With Apatinib in Advanced ICC: A Single-arm Phase II Study Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer Guadecitabine and Durvalumab in Treating Patients With Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Response of Hepatic Tumors to Radioembolization Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer Cabozantinib (XL-184) Monotherapy for Advanced Cholangiocarcinoma Bortezomib in Intrahepatic Cholangiocellular Carcinoma Stereotactic Body Radiotherapy for Liver Tumors Capecitabine and Y-90 Radioembolization in Treating Patients With Advanced Bile Duct Cancer in the Liver That Cannot Be Removed by Surgery Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC) Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma A Study of Second-line Treatment With Apatinib for Advanced Intrahepatic Cholangiocarcinoma Radiation Therapy vs. Observation Following Gemcitabine and Cisplatin for Inoperable Localized Liver Cancer Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery in Patients With High-Risk Liver Bile Duct Cancer Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC) Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC Lenvatinib Plus PD-1 Antibody for Unresectable ICC HAIC Versus Systemic Chemotherapy for Unresectable ICC Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations mFOLFIRNOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma Stereotactic Body Radiotherapy for Hepatocellular Carcinoma, and Intrahepatic Cholangiocarcinoma Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma A Study of Second-line Treatment With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma Analysis of Oncogenes in Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma in Tumor Tissue Samples COmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable inTrahepatic Cholangiocarcinoma Durvalumab in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection Liver Transplantation for Early Intrahepatic Cholangiocarcinoma A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma 90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma PD-1 Antibody (SHR-1210) Plus Apatinib and Capecitabine in Patients With Intrahepatic Cholangiocarcinoma After Surgery Safety and Efficacy Evaluation of MUC-1 CART in the Treatment of Intrahepatic Cholangiocarcinoma A Trial of Systemic Chemotherapy in Combination With Conventional Transarterial Chemoembolization in Patients With Advanced Intra-Hepatic Cholangiocarcinoma Role of Bile Duct Resection in Major Hepatectomy Due to Intrahepatic Cholangiocarcinoma Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma A Pilot Study of Neoadjuvant Therapy With Gemcitabine and Cisplatin in Patients With Resectable or Unresectable Intrahepatic Cholangiocarcinoma Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma Calcitriol in Advanced Intrahepatic Cholangiocarcinoma Prognosis of Resection and Radiotherapy in the Treatment of Intrahepatic Cholangiocarcinoma Patients VEGF Signaling Promotes Cell Growth and Metastasis in Intrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway Next Generation Sequencing in Intrahepatic Cholangiocarcinoma

Brief Title

Infusion System for Hepatic Cancer

Official Title

Combined Infusion System to Deliver Chemotherapy Regionally to the Liver

Brief Summary

      This is a single-site, open-label continued access study/treatment protocol under a treatment
      IDE. In addition to treating patients, the primary objective of this study is to assess the
      safety of using the Medtronic SynchroMed II programmable pump combined with the Intera
      tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR) drug for
      adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the
      liver or intrahepatic cholangiocarcinoma.

      After successful implantation, the combined pump and catheter system will be evaluated using
      a nuclear scan in the postoperative period, which is standard procedure to confirm that the
      pump is functioning prior to HAI of FUDR. Monitoring for safety will include a record of
      residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is
      being used for chemotherapy infusion) to determine if the pump is still working and
      surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a
      pump or catheter problem. Patients will be monitored for the safety of the pump/catheter
      combination for up to 5 years or pump removal/study withdrawal.
    



Study Type

Interventional


Primary Outcome

Number of Targeted Adverse Events (TAEs)


Condition

Colorectal Cancer Metastatic to Liver

Intervention

Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)

Study Arms / Comparison Groups

 Hepatic Artery Infusion (HAI) Therapy
Description:  Eligible patients will be implanted with a device that combines components of two commercially available drug delivery pumps to administer regional chemotherapy (FUDR) to the liver. Specifically, a Medtronic pump is being used with an Intera tapered catheter, instead of the Medtronic catheter.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

100

Start Date

February 8, 2021

Completion Date

July 2029

Primary Completion Date

July 2029

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must be greater than or equal to 18 years of age

          -  Have a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to liver or
             intrahepatic cholangiocarcinoma

          -  At the time of pump placement, patients will either have unresectable,
             chemotherapy-responsive disease or they will be undergoing resection with planned
             postoperative HAI

          -  Be deemed appropriate for pump chemotherapy by both a medical oncologist and a
             surgical oncologist

          -  Provision of signed and dated informed consent form

        Exclusion Criteria:

          -  Known active infection

          -  Is pregnant or breastfeeding or expecting to conceive children within the projected
             duration of the trial
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 215-662-7539, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04684862

Organization ID

UPCC 19220


Responsible Party

Sponsor-Investigator

Study Sponsor

Ronald DeMatteo, M.D.


Study Sponsor

, , 


Verification Date

February 2021